surgical technique - smith & nephew · the surgeon may consider other imaging modalities such...

Surgical Technique

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Nota Bene

The technique description herein is made available to the healthcare professional to illustrate the author’s suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the specific patient.

ECHELON™ Revision Hip System Surgical Technique

Contents

ECHELON reamer chart ........................................................................ 2

Porous implants ................................................................................... 3

Cemented implants .............................................................................. 4

Preoperative planning and templating ................................................. 5

Porous-coated implant specifications ................................................. 7

Porous-coated implant surgical technique .......................................... 9

Cemented implant specifications ........................................................ 21

Cemented implant surgical technique ................................................. 23

Catalog information .............................................................................. 35

Indications ............................................................................................ 53

Contraindivcations ................................................................................ 53

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Cemented stem

190mm Straight

260mm245mm

260mm245mm

190mm175mm

260mm Bowed

175mm 225mm

175mm190mm

Porous stem

ECHELON™ reamer chart

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Porous implants

190mm Straight

1 Suzuki, Y., et al, Effect of Cementless Femoral Stem Design on Bone Strains and Torsional Stability, A Scientific Exhibit at the 2000 AAOS Meeting; Orlando, Florida.

Porous coating — ROUGHCOAT™ porous coating increases the friction between the implant and bone, improving implant stability and providing a porous surface for bone ingrowth.

Driving platform — The ECHELON™ implants feature a threaded driving platform with an elliptical slot for rotational and axial implant control during insertion.

Neck geometry — Circulotrapezoidal neck provides increased range of motion compared to a circular neck of the same strength.

Collar options — A standard collar and +15mm calcar platform are available to match the implant to the proximal defect.

Distal slot — The distal slot eases stem insertion, reduces the risk of fracture,1 and reduces distal stem stiffness.

Hydroxyapatite — A 50 micron layer of hydroxyapatite is applied to the fully porous coated stem.

Shoulder relief — The lateral shoulder is rounded to minimize the risk of fracturing the greater trochanter during stem insertion.

Lateral proximal flare — The ECHELON system has a 3° proximal anterior/posterior flare to improve proximal fill, without preventing implant seating.

Distal flutes — The ECHELON system offers distal flutes to increase rotational stability.

Distal bullet tip — The bullet tip reduces the stress between the distal implant tip and the bone to minimize thigh pain.

Size range — The ECHELON system porous stems are offered in 1mm increments to minimize bone removal and provide optimum canal fill.

260mm Bowed

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Cemented implantsDouble taper proximal geometry — Limits shear stresses and promotes compressive stress transfer between the cement and implant.

Proximal A/P groove — Increases rotational stability without increasing cement stresses.

Trapezoidal distal cross section — Improves resistance to rotation.

Neck geometry — Circulotrapezoidal neck provides increased range of motion compared to a circular neck of the same strength.

Collar options — A standard collar and +15mm calcar platform are available to match the implant to the proximal defect.

225mm

ECHELON™ implants are made from Cobalt Chromium material.

An optimized 12/14 taper is used to lock the modular head to the stem.

175mm

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Preoperative planning and templatingThe general principles of patient selection and sound surgical judgment apply. The correct selection of the implant is very important. The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age, activity levels, weight, bone and muscle conditions, prior surgery and anticipated future surgeries, etc. Generally, the largest cross-section component which will allow adequate bone support to be maintained is preferred. Literature has shown a higher likelihood of revision in younger, heavier, or more active patients. Specifically, the risk of complication is greater in obese and morbidly obese patients. Failure to use the optimum-sized component may result in loosening, bending, cracking, or failure of the component and/or bone, resulting in revision surgery.

Preoperative planning for a revision total hip arthroplasty is the first, and most important step, requiring at a minimum a standard set of radiographs, which includes an antero-posterior (A-P) radiograph of the pelvis and a lateral radiograph of the affected hip. Depending on the length of the existing femoral component several additional radiographs may be necessary. Specifically, the A-P and lateral radiographs should include the entire femoral component. On occasion a full length A-P radiograph of the entire femur may be necessary. As part of the preoperative work-up, the surgeon may consider other imaging modalities such as bone scans and computerized tomography (CT). However, these are typically not necessary for preoperative planning.

Determine the appropriate classification for the femoral revision, for example, the Paprosky Revision Classification.1 This will aid in determining the appropriate type, size and position of the revision stem you will need.

As with primary THA preoperative planning, establishing proper leg length requires assessment of a number of clinical and radiographic parameters. Establishing the proper reference lines requires using a horizontal line between the inferior portion of the teardrop as well as a horizontal line between the inferior margin of the obturator foramen and ischial tuberosity. Due to the often distorted anatomy of revision cases, utilizing all three reference lines may be necessary.

Similarly, due to bony defects on the femoral side, a combination of anatomic landmarks such as the superior margin of the greater trochanter and inferior margin of the lesser trochanter must be utilized. These obviously need to be compared to similar points on the contralateral compared to similar points on the contralateral side using the A-P radiograph.

1 Paprosky W, Aribindi R. Hip replacement: treatment of femoral bone loss using distal bypass fixation. Instr Course Lect 2000; 49:119-130.

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Any pelvic obliquities and/or spinal deformities must also be taken into account based on radiographic and clinical assessments. The consideration of all relevant factors is necessary to successfully restore the patient’s proper leg length.

Surgeon tip The use of simple wooden blocks during the preoperative physical examination of the patient is very useful, as is a discussion of the patient’s perceived length elicited during their preoperative interview.

The A-P radiograph is also critical in assessing proper femoral offset. If there is a native hip on the contralateral side, the proper offset can be determined by the horizontal distance between the center of rotation of the head and the anatomic axis of the femur. If there is a well-functioning total hip prosthesis on the contralateral side, a similar assessment can be made using the ECHELON™ templates. Templates are available in digital and acetate formats. Consult your Smith & Nephew representative for assistance in obtaining templates.

Difficulties sometimes arise when the contralateral hip is deformed or has a malfunctioning THA. Additional problems may be encountered if the ipsilateral acetabulum has failed or has a protrusion deformity. In these cases it is up to the surgeon to determine intraoperatively what the proper offset should be so as to achieve a hip that is without impingement in all physiological positions.

Once the bone stock has been assessed and proper leg length and offset have been established the surgeon should template the femur to determine the appropriate stem type, length and size. Stem length will be based on the amount of bone loss. Stable fixation may be obtained with 4 to 5cm of “scratch fit”.2

2 Revision Total Hip and Knee Arthroplasty / edited by Daniel J Berry, et al. Lippincott Williams & Wilkins; Philadelphia, PA: 295.

Preoperative planning and templating

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Porous-coated implant specifications

General specifications:

Cobalt Chromium material

Neck shaft angle 131°

Porous straight stem length 190mm*

Extensively coated straight stem porous coating length 140mm**

Porous bowed stem length 260mm*

Bowed stem porous coating length 210mm**

The porous stem trial is 1.25mm smaller than the implant.

The broach is 0.5mm smaller than the implant.

* Stem length is measured from the standard collar area to the distal tip. ** Porous coating length is measured from the shoulder to the distal end of the coating.

Neck height (mm)Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16

Standard Collar 11-20 33 35 38 40 43 63

+15mm Calcar 11-20 48 50 53 55 58 61

Neck length (mm)Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16

11-12 34 37 41 45 49 53

13-17 36 39 43 47 51 55

18-22 38 41 45 49 53 57

Neck offset (mm)Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16

11-12 38 40 43 46 49 52

13-17 43 45 48 51 54 57

18-22 48 50 53 56 59 62

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Porous straight stem 190mm*

Neck length

Neck offset

Neck height

Stemsize

Porous bowed stem-260 mm

Bowed stem porous coating length 210 mm

Neck length

Neck offset

Neck height calcar stem

Stemsize

Available in standard and +15mm calcar options.

* Porous coating length of ECHELON™ Porous Plus HA is 175mm.

Porous-coated implant specifications

Straight stem porous coating length 140mm

Available in standard collar and +15mm calcar options.

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Porous-coated implant surgical technique

Optional surgical approachSurgical exposure can be improved by an extended trochanteric osteotomy. The greater trochanter, in continuity with a strip of the lateral proximal femoral cortex, is osteotomized to permit intramedullary access to remove the femoral component. The revision stem should bypass the distal extent of the osteotomy by two to three canal diameters. Place a cerclage cable slightly distal to the osteotomy before reaming, broaching, and inserting the stem to minimize the risk of propagating a crack or fracture. Once the final components are implanted, the osteotomy is reduced. In order to reduce the osteotomized bone fragment in its anatomic position, it may be necessary to shape the endosteal surface of the bone fragment with a curette or burr to fit against the lateral portion of the femoral component. To gain adequate proximal support and reduce the risk of implant failure, the use of adjunctive devices such as cables, cerclage wires, struts, etc. is recommended. Because of the intramedullary exposure gained by extended trochanteric osteotomy, over-reaming is less likely to be necessary to insert a bowed femoral stem than if the surgery is performed without an extended trochanteric osteotomy.

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Femoral neck osteotomy

An osteotomy guide is available for proximal bone resection. The angled slot is for a standard collar stem, and the proximal horizontal slot is for a +15mm calcar stem. The osteotomy guide has a vertical scale in 5mm increments to help gauge neck height.

Resect the proximal bone by cutting through the osteotomy slot that corresponds to the implant collar type. When a calcar-type stem is selected, ensure that sufficient bone has been removed to allow the collar to fully seat.

Femoral preperation

The starter reamer is specifically designed with a bullet tip to open the proximal aspect of the femur to remove bone from the greater trochanteric region. The presence of this bone will be largely dependent on the stem previously implanted and the stem removal process. Use the starter reamer to remove lateral bone as shown. Removing lateral bone is important for maintaining neutral stem placement in respect to the femoral axis.

Caution Take care when handling reamers and broaches as they are sharp and may damage surgical gloves and soft tissue.

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Femoral reaming (straight stems)

Rigid femoral reamers in 0.5mm increments are available for the porous straight stems.

The stem size is measured at the maximum diameter of the distal porous coating. The maximum diameter of the flutes is equal to the diameter of the porous coating.

Start reaming with a reamer 4 to 6mm smaller than the templated size or a reamer that has little or no resistance in the femoral canal.

For a line-to-line fit, ream the canal in 0.5mm increments until the last reamer matches the selected implant size. The canal can also be reamed 0.5mm smaller than the size for a tighter distal fit. The final reamer size should be based on bone quality, anatomy, and surgeon preference.

The stem length is measured from the standard collar area to the distal tip of the implant. Reaming depth is measured from the selected collar level to the distal tip of the implant. Use the straight implant reaming chart to determine the reaming depth for the porous straight implants. Seat the reamer to the appropriate depth mark on each reamer.

Porous straight 190mm implant reaming chart

Collar optionsReaming depth from medial resection level

Standard collar 190mm

+15mm calcar 175mm

Porous straight stemstandard collar 190mm

Porous straight stem +15mm calcar 175mm

Stemsize

Standard Collar (190mm)

+15mm Calcar (175mm)

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Femoral reaming (bowed stems)

Thin shaft reamers are available for the porous bowed stems. Ream the canal in 0.5mm increments until the reamer size is 0.5mm larger than the selected implant. The canal can be reamed larger if required to seat the implant. The final reamer size should be based on bone quality, anatomy, and surgeon preference.

The stem length is measured from the standard collar area to the distal tip of the implant. Reaming depth is measured from the selected collar level to the distal tip of the implant. Use the bowed implant reaming chart to determine the reaming depth for the bowed porous implants.

Surgeon tip I often ream the bowed stems line-to-line. If the fit is too tight as determined during implant insertion, the stem is removed and the canal reamed 0.5mm larger. — Douglas Becker, MD

Stemsize

Porous bowed stem standard collar 260mm

Porous bowed stem +15mm calcar 245mm

Porous Bowed 260mm implant reaming chart

Collar optionsReaming depth from medial resection level

Standard Collar 260mm

+15mm Calcar 245mm

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+15mm Calcar

Femoral broaching

Begin broaching two sizes smaller than the size of the last femoral reamer. The final broach should match the size of the selected implant, except for implant sizes 21 and 22. When using these larger implants the final broach should be a size 20. The femoral broaches are 0.5mm smaller than the porous coating level of the implant.

Standard collar implant broaching

For a standard collar implant, the proximal medial aspect of the broach should be flush with the osteotomy level.

Calcar implant broaching

The femoral broach has two black lines on the proximal medial section. The proximal line indicates the level of the +15mm calcar. When implanting a calcar-style implant, seat the broach so that the appropriate black line meets the medial resection level.

Surgeon tip If I have used an extended trochanteric osteotomy for removal of cement

and/or the femoral components to be revised, I like to close the osteotomy prior to canal preparation. I do this with bone clamps during preparation of the canal and then trial with the bone clamps in place. If I am satisfied with what I learned from the trial, I then apply my definitive cable fixation to the osteotomy prior to inserting the final stem. I find this greatly enhances the fixation that I obtain proximally as opposed to the more usual technique which is to insert the stem and then re-attach the osteotomized trochanter with cables. — James Waddell, MD, FRCS(C)



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Standard collar calcar preparation

A calcar reamer is available for standard collar implants. With the final broach fully seated, remove the broach handle and ream the calcar bone with the calcar reamer.

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*Skirted femoral head

Trialing

Trialing with the broach

Seat the final broach to the appropriate level for the selected implant (fully seated for standard collar, proximal black line for +15mm calcar). Remove the broach handle and place the matching trial neck onto the broach post. Fully engage the desired trial femoral head on the trial neck and reduce the hip to assess stability and range of motion.

Note The broach length is shorter than the implant. Also the broach is 0.5mm smaller than the implant.

Femoral neck length options

Global trial head color 22mm 28mm 32mm 36mm 40mm 44mm

Green — XS/-3 XS/-3 XS/-3 XS/-3 XS/-3

Rust S/+0 S/+0 S/+0 S/+0 S/+0 S/+0

Brown M/+4 M/+4 M/+4 M/+4 M/+4 M/+4

Gray L/+8 L/+8 L/+8 L/+8 L/+8 L/+8

Blue XL/+12* XL/+12* XL/+12* XL/+12 XL/+12 XL/+12

Black — XXL/+16* XXL/+16* — — —

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Standard collar trialing

Calcar trialing

Trialing (continued)

Trialing with the trial stem

When trialing with the trial stem, select the trial size that corresponds to the last broach used. The trial stem is 1.25mm smaller than the implant (diameter only) to prevent the trial from locking in the canal.

A modular collar is available to convert the standard collar trial to a +15mm. Insert the trial collar into the proximal hole for a +15mm calcar implant. Place the desired trial femoral head on the trial stem and reduce the hip to assess stability and range of motion.

Surgeon tip To get a better feel for the distal fit of the stem, I like to use the next larger trial size from the last reamer diameter. On a straight stem, for example, if the last reamer is a 14.5mm, it’s probably useful to insert the 16mm trial. This gives me a good idea how tight the actual implant will be. — Cecil Rorabeck, MD, FRCS(C)

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Implant insertion

Assemble the threaded stem inserter by inserting the stem inserter pommel through the stem inserter frame. Engage the tip of the stem inserter frame into the stem driver slot on the selected implant and turn the pommel to thread the inserter onto the implant. Fully tighten the pommel before impaction.

Straight Stem Insertion

Insert the implant into the canal with hand pressure and verify proper implant version. Once the implant flutes have engaged the bone, the implant version cannot be changed without removing the implant. Use firm mallet blows to seat the implant. The implant can be removed by striking the underside of the threaded stem driver with a mallet.

Surgeon tip When using a cylindrical stem design, I believe it is important to know the exact dimensions of the reamers and implants used. Therefore, especially with bowed stems, I will use a ring gauge to measure the reamer and implant to 0.5mm. Based on these measurements, I can decide whether to ream line-to-line or otherwise. — Robert Barrack, MD

Surgeon tip In cases of considerable bone ectasia proximally, I find it helpful to use prophylactic cables or wires about the proximal femur. The bone is very fragile and propagation cracks can occur easily. — James Waddell, MD, FRCS(C)

Caution Do not use the Stem Inserter Pommel as a standalone instrument, either for stem insertion or removal.

Caution To gain adequate proximal support and reduce the risk of implant failure, the use of adjunctive devices such as cables, cerclage wires, struts, etc. is recommended.

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Bowed Stem insertion

Assemble the bowed stem to the stem inserter with the same technique as the straight stem. Implant version must be correct before the implant encounters resistance in the canal. If the bowed stem stops progressing during insertion, remove the implant and enlarge the canal with a larger size thin shaft reamer.

Note A fully seated bowed stem will be extremely difficult to remove from the femur and may require an osteotomy to remove.

Surgeon tip If the implant does not advance visibly with forceful blows, the distance from the collar to the calcar should be measured in millimeters and re-measured after a series of blows to insure that it’s advancing steadily. If there’s no advancement with several hard blows, the pitch has changed, and the stem is still proud, the stem should be extracted and the canal over-reamed. — Robert Barrack, MD

Surgeon tip For a bowed stem, I find it occasionally necessary to introduce the stem initially for the first few centimeters with the bow turned 90º to its ultimate orientation and, once the tip of the stem has passed the initial proximal bow (anteversion), rotate the stem back to its desired position and gradually impact the stem. — James Waddell, MD, FRCS(C)

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Implant trialing

Once the implant is fully seated, perform a final trial reduction to determine appropriate neck length. Fully engage the desired trial femoral head on the implant and reduce the hip to assess stability and range of motion.

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Femoral head assembly

Clean and dry the taper with a sterile cloth, place the prosthetic femoral head on the neck taper and firmly impact several times with a femoral head impactor and a mallet.

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General Specifications:

Cobalt Chromium material

Neck shaft angle 131°

*Stem length is measured from the standard collar area to the distal tip.

Cemented implant specifications

Neck height (mm)Size –3 +0 +4 +8 +12 +16

Standard Collar 12, 14, 16 33 35 38 40 43 46

+15mm Calcar 12, 14, 16 48 50 53 55 58 61

Stem specificationsStem size

Stem length* (mm)

Final broach size

Final reamer size

Distal stem size

Cement mantle

12 175/300 12 12mm 9mm 1.5mm

14 175/300 14 14mm 11mm 1.5mm

16 175/225 16 16mm 13mm 1.5mm

Neck offset (mm)Size –3 +0 +4 +8 +12 +16

12 38 40 43 46 49 52

14 43 45 48 51 54 57

16 43 45 48 51 54 57

Neck length (mm)Size –3 +0 +4 +8 +12 +16

12 34 37 41 45 49 53

14 36 39 43 47 51 55

16 36 39 43 47 51 55

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Cemented implant specifications

Cemented stem 175mm

Distal stem size

Cemented stem 225mm*

Distal stem size

Neck offset

Neck height

Neck length

Neck offset

Neck height calcar stem

Neck length

* 300mm length also available

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Cemented implant surgical technique

Femoral neck osteotomyAn osteotomy guide is available for proximal bone resection. The angled slot is for a standard collar stem, and the proximal horizontal slot is for a +15mm calcar stem. The osteotomy guide has a vertical scale in 5mm increments to help gauge neck height.

Resect the proximal bone by cutting through the osteotomy slot that corresponds to the implant collar type. When a calcar-type stem is selected, ensure that sufficient bone has been removed to allow the collar to fully seat.

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Standard Collar (190mm)

+15mm Calcar (175mm)

*Reaming depth includes 1.5cm for the distal cement plug.

Femoral reaming (175mm stems)

Rigid femoral reamers are available for the 175mm cemented stems. Cemented implants are offered in three sizes: 12, 14 and 16. It is important to note that the size corresponds to the size of the recommended final reamer and broach, not the actual implant size.

Set the appropriate depth mark at the medial resection level. The stem length is measured from the standard collar area to the distal tip for all cemented implants. Ream to the size of the implant for a 1.5mm cement mantle per side. Use the following chart to determine the reaming depth for the 175mm cemented implants. Reaming depth is measured from the medial resection to the distal cement plug.

Stemsize

+15mm calcar 160mm


Cemented 175mm stem height

Cemented 175mm implant reaming chart

Collar optionsStem length measured from collar

Reaming depth from medial resection level*

Standard Collar 175mm 190mm

+15mm Calcar 160mm 175mm

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*Reaming depth includes 1.5cm for the distal cement plug.

Femoral reaming (225mm and 300mm stems)

Use thin shaft reamers for the 225mm and 300mm cemented stems. Ream the canal in 0.5mm increments until the reamer size matches the selected implant. This reaming method will provide a minimum 1.5mm cement mantle on each side of the implant.

It is unusual that axial reaming is necessary in this revision surgery. Preservation of cancellous bone is critical for allowing intrusion of cement into the cancellous bed thus enhancing fixation.

Prior to broaching it is necessary to remove the neocortex that has formed around the previous implant. Failure to do this prevents the cement-bone bond.

The stem length is measured from the standard collar area to the distal tip of the implant. Reaming depth is measured from the selected collar level to the distal cement plug. Stem

size

+15mm calcar 210mm


Cemented 225mm stem length

Cemented 225mm and 300mm implant reaming chart

Collar optionsStem length measured from collar

Reaming depth from medial resection level*

Standard Collar 225mm/300mm 240mm/315mm

+15mm Calcar 210mm 225mm

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+15mm Calcar

Femoral broaching

Begin broaching two sizes smaller than the size of the last femoral reamer. The final broach should match the size of the selected implant and the last reamer used. The femoral broach provides a 1.5mm cement mantle per side.


For a standard collar implant, the proximal medial aspect of the broach should be flush with the osteotomy level.


The femoral broach has two black lines on the proximal medial section. The proximal line indicates the level of the +15mm calcar. When implanting a calcar-style implant, seat the broach so that the appropriate black line meets the medial resection level.

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Standard collar calcar preparation

A calcar reamer is available for standard collar implants. With the final broach fully seated, remove the broach handle and ream the calcar bone with the calcar reamer.

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Standard collar trialing Calcar trialing

Trialing

Trialing can be performed using either the broach or trial stem.

Trialing with the broach

Seat the final broach to the appropriate level for the selected implant (fully seated for standard collar, proximal black line for +15mm calcar). Remove the broach handle and place the matching trial neck onto the broach post. Place the desired trial femoral head on the trial neck and reduce the hip to assess stability and range of motion.

Note The broach length is shorter than the implant.

Trialing with the trial stem

When trialing with the trial stem, select the trial size that corresponds to the last broach used. The trial stem is the same size as the implant (for cemented). If increased stability is needed when trialing, use the femoral broach as a trial. A modular collar is available to convert the standard collar trial to a +15mm. Insert the trial collar into the proximal hole for a +15mm calcar implant. Place the desired trial femoral head on the trial stem and reduce the hip to assess stability and range of motion.

Femoral neck length options

Global trial head color 22mm 28mm 32mm 36mm 40mm 44mm

Green — XS/-3 XS/-3 XS/-3 XS/-3 XS/-3

Rust S/+0 S/+0 S/+0 S/+0 S/+0 S/+0

Brown M/+4 M/+4 M/+4 M/+4 M/+4 M/+4

Gray L/+8 L/+8 L/+8 L/+8 L/+8 L/+8

Blue XL/+12* XL/+12* XL/+12* XL/+12 XL/+12 XL/+12

Black — XXL/+16* XXL/+16* — — —

*Skirted femoral head

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Preparing the femoral canal

Use a curette to remove any grossly loose cancellous bone. Irrigate the canal with saline solution and pulsatile lavage to remove all debris. Continue preparing the femur with the femoral canal brush to remove any remaining weak cancellous bone, blood clots, and marrow fats. Repeat lavaging as necessary to remove all remaining debris.

Surgeon tip While awaiting the appropriate cement texture, I find it helpful to remind the anesthesiologist to keep the patient’s blood pressure stable and relatively low. Epinepherine-soaked rags are placed in the canal at this time as well, preventing additional bleeding. — Kevin Garvin, MD

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Placing the BUCK™ Cement Restrictor

The proximal flange of the cement restrictor should always be larger than the distal canal diameter. Screw the cement restrictor onto the inserter using a clockwise motion. Insert the device to the level of the medullary canal that has been predetermined. Once this level is reached, disengage the restrictor from the inserter using a counterclockwise twisting motion. Remove the inserter from the medullary canal. If it is necessary to remove the restrictor prior to cement insertion, it can be reattached to the inserter rod and pulled out of the canal. The surgeon may adjust the restrictor as many times as required.

Surgeon tip I find it helpful to place a small 10cc volume of cement distal to the plug if the canal is large and the plug does not remain stable. — Kevin Garvin, MD

Drying the femoral canal

Connect OR suction to the femoral suction absorber handle. Insert the femoral absorber into the femoral canal to dry the canal while mixing the cement.

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Injecting cement

After removing the femoral canal suction absorber, immediately insert the nozzle of the cement gun deep into the femoral canal. Beginning at the distal end of the femoral canal, inject cement into the canal in retrograde fashion. Continue injecting cement until the canal is completely full and the distal tip of the nozzle is clear of the canal.

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Pressurizing cement

Break off the long nozzle and place the femoral pressurizer over the short nozzle. Place the pressurizer against the proximal femur. This will occlude the canal and pressurize the cement. Maintain firm pressure for 30 – 60 seconds, depending on cement viscosity, to allow good cement interdigitation into trabecular bone. Withdraw the pressurizer from the canal and remove any extruded cement around the periphery of the pressurizer.

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Implant insertion

Engage the tip of the stem inserter into the stem driver slot on the selected implant. Insert the implant into the canal with hand pressure while verifying proper implant alignment.

Implant trialingOnce the implant is fully seated and the cement has cured, perform a final trial reduction to determine appropriate neck length. Place the desired trial femoral head on the implant and reduce the hip to assess stability and range of motion.

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Femoral head assembly

Clean and dry the taper with a sterile cloth, place the prosthetic femoral head on the neck taper and firmly impact several times with a femoral head impactor and a mallet.

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Size Std Collar +15mm Calcar

12R 7134-0512 7134-0712

13R 7134-0513 7134-0713

14R 7134-0514 7134-0714

15R 7134-0515 7134-0715

16R 7134-0516 7134-0716

17R 7134-0517 7134-0717

18R 7134-0518 7134-0718

19R 7134-0519* 7134-0719*

20R 7134-0520* 7134-0720*

21R 7134-0521* 7134-0721*

22R 7134-0522* 7134-0722*

Standard +15mm

Catalog information

Porous Plus HA Implants (190mm)Size Standard Collar +15mm Calcar

13 7134-2013 7134-3013

14 7134-2014 7134-3014

15 7134-2015 7134-3015

16 7134-2016 7134-3016

17 7134-2017 7134-3017

18 7134-2018 7134-3018

Standard +15mm

Porous Bowed Implants (260mm)Size Std Collar +15mm Calcar

12L 7134-0412 7134-0612

13L 7134-0413 7134-0613

14L 7134-0414 7134-0614

15L 7134-0415 7134-0615

16L 7134-0416 7134-0616

17L 7134-0417 7134-0617

18L 7134-0418 7134-0618

19L 7134-0419* 7134-0619*

20L 7134-0420* 7134-0620*

21L 7134-0421* 7134-0621*

22L 7134-0422* 7134-0622*

Standard +15mm

Extensively Coated Porous Straight Implants (190mm)Size Standard Collar +15mm Calcar

11 7134-0111 7134-0211

12 7134-0112 7134-0212

13 7134-0113 7134-0213

14 7134-0114 7134-0214

15 7134-0115 7134-0215

16 7134-0116 7134-0216

17 7134-0117 7134-0217

18 7134-0118 7134-0218

19 7134-0119* 7134-0219*

20 7134-0120* 7134-0220*

*Available in limited quantities in the US only. If implant is not available, it may be substituted with a HA implant. Contact your local represnetative for further information.

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+15mmStandard

Neck Length 22mm 26mm 28mm 32mm 36mm

-3 — — 7134-2803 7134-3203 7134-3603

+0 7134-2200 7134-2600 7134-2800 7134-3200 7134-3600

+4 7134-2204 7134-2604 7134-2804 7134-3204 7134-3604

+8 7134-2208 7134-2608 7134-2808 7134-3208 7134-3608

+12 7134-2212 7134-2612 7134-2812 7134-3212 7134-3612

+16 — — 7134-2816 7134-3216 —

Size Length (mm) Standard Collar +15mm Calcar

12 175 7131-0112 7131-0312

12 225 7131-0212 7131-0412

14 175 7131-0114 7131-0314

14 225 7131-0214 7131-0414

16 175 7131-0116 7131-0316

16 225 7131-0216 7131-0416

12L 300 7131-4112 –

12R 300 7131-5112 –

14L 300 7131-4114 –

14R 300 7131-5114 –

Cemented Implants

OXINIUM™ 12/14 Taper Femoral Heads

BioloxTM forte Ceramic Femoral Heads 12/14 Taper

Biolox delta Ceramic Femoral Heads 12/14 Taper

Neck length 28mm 32mm 36mm

+0 (short) 71330280 71330320 71332084

+4 (medium) 71330284 71330324 71332085

+8 (long) 71330288 71330328 71332086

Neck length 32mm 36mm 40mm

+0 (short) 76539160 76539165 71346004

+4 (medium) 76539161 76539166 71346005

+8 (long) 76539162 76539167 71346006

* 7134-2340 OXINIUM 40mm Modular Femoral Head* 7134-2344 OXINIUM 44mm Modular Femoral Head

Catalog information

37

Neck Length

22mm 26mm 28mm 32mm 36mm

-3 — — 7130-2803 7130-3203 7130-3603

+0 7130-2200 7130-2600 7130-2800 7130-3200 7130-3600

+4 7130-2204 7130-2604 7130-2804 7130-3204 7130-3604

+8 7130-2208 7130-2608 7130-2808 7130-3208 7130-3608

+12 7130-2212 7130-2612 7130-2812 7130-3212 7130-3612

+16 — — 7130-2816 7130-3216 –

LengthNeck Color 22mm 28mm 32mm 36mm 40mm 44mm

XS/-3 Green — 7510-0843 7510-0849 7510-0855 7510-0868 7510-0873

S/+0 Rust 7510-0839 7510-0844 7510-0850 7510-0856 7510-0869 7510-0874

M/+4 Brown 7510-0840 7510-0845 7510-0851 7510-0857 7510-0870 7510-0875

L/+8 Gray 7510-0841 7510-0846 7510-0852 7510-0858 7510-0871 7510-0876

XL/+12 Blue 7510-0842 7510-0847 7510-0853 7510-0859 7510-0872 7510-0877

XXL/+16 Black — 7510-0848 7510-0854 — — —

Titanium Modular Neck Sleeve 12/14 Taper

CoCr 12/14 Taper Femoral HeadsCobalt Chromium — ASTM F 799

Global Femoral Head Trial 12/14 Taper

Neck length

-4 71344245

+0 71344247

Use with 40mm and 44mm OXINIUM and CoCr Modular Femoral Heads

Neck length

+4 71344248

+8 71344249

7134-2340 OXINIUM™ 40mm Modular Femoral Head

7134-2344 OXINIUM 44mm Modular Femoral Head

38

Osteotomy GuideCat. No. 7136-4100

Box OsteotomeCat. No. 7136-4002

Femoral Canal FinderCat. No. 7136-4001

T-HandleCat. No. 7136-4006

Anteversion Handle (2 per set)Cat. No. 7136-4012

Broach Handle (2 per set)

Cat. No. 7136-4007

Proximal Reamer Cat. No. 7136-4015

Catalog information

39

Rigid Reamer Cat. No. Size

7135-0090 9mm

7135-0095 9.5mm

7135-0100 10mm

7135-0105 10.5mm

7135-0110 11mm

7135-0115 11.5mm

7135-0120 12mm

7135-0125 12.5mm

7135-0130 13mm

7135-0135 13.5mm

7135-0140 14mm

7135-0145 14.5mm

Cat. No. Size

7135-0150 15mm

7135-0155 15.5mm

7135-0160 16mm

7135-0165 16.5mm

7135-0170 17mm

7135-0175 17.5mm

7135-0180 18mm

7135-0185 18.5mm

7135-0190 19mm

7135-0195 19.5mm

7135-0200 20mm

Cat. No. Size

7136-7010 10

7136-7011 11

7136-7012 12

7136-7013 13

7136-7014 14

7136-7015 15

Cat. No. Size

7136-7101 11-12

7136-7102 13-17

7136-7103 18-20

Stem Inserter FrameCat. No. 7136-4008

Stem Inserter PommelCat. No. 7136-4011

Trial Collar (2 per set)Cat. No. 7136-7034

Revision Trial Neck

BroachCat. No. Size

7136-7016 16

7136-7017 17

7136-7018 18

7136-7019 19

7136-7020 20

40

Calcar ReamerCat. No. 7136-4004

Femoral Head ImpactorCat. No. 7136-4009

Cat. No. Size

7136-8011 11

7136-8012 12

7136-8013 13

7136-8014 14

7136-8015 15

Cat. No. Size Length

7136-8512 12 175mm

7136-8514 14 175mm

7136-8516 16 175mm

7136-8612 12 225mm

7136-8614 14 225mm

7136-8616 16 225mm

7136-8712 12 left 300mm

7136-8714 14 left 300mm

7136-8812 12 right 300mm

7136-8814 14 right 300mm

Cemented Stem InserterCat. No. 7136-4014

Porous Straight Stem Trial

Cemented Stem Trial

Cat. No. Size

7136-8016 16

7136-8017 17

7136-8018 18

7136-8019 19

7136-8020 20

U-JointCat. No. 7136-7032

R-T SlaphammerCat. No. 110211

Catalog information

41

Cat. No. Size

7135-1900 9mm

7135-1100 10mm

7135-1110 11mm

7135-1115 11.5mm

7135-1120 12mm

7135-1125 12.5mm

7135-1130 13mm

7135-1135 13.5mm

7135-1140 14mm

7135-1145 14.5mm

7135-1150 15mm

7135-1155 15.5mm

7135-1160 16mm

7135-1165 16.5mm

7135-1170 17mm

Cat. No. Size

7136-8312 12 Left

7136-8313 13 Left

7136-8314 14 Left

7136-8315 15 Left

7136-8316 16 Left

7136-8317 17 Left

7136-8318 18 Left

7136-8319 19 Left

7136-8320 20 Left

7136-8321 21 Left

7136-8322 22 Left

Porous Bowed Stem Trial

Thin Shaft Reamer

Cat. No. Size

7136-8412 12 Right

7136-8413 13 Right

7136-8414 14 Right

7136-8415 15 Right

7136-8416 16 Right

7136-8417 17 Right

7136-8418 18 Right

7136-8419 19 Right

7136-8420 20 Right

7136-8421 21 Right

7136-8422 22 Right

Cat. No. Size

7135-1175 17.5mm

7135-1180 18mm

7135-1185 18.5mm

7135-1190 19mm

7135-1195 19.5mm

7135-1200 20mm

7135-1205 20.5mm

7135-1210 21mm

7135-1215 21.5mm

7135-1220 22mm

7135-3225 22.5mm

7135-3230 23mm

7135-3235 23.5mm

7135-3240 24mm

42

VORTEX™ Vacuum MixerCat. No. 7127-0070

MIXOR Hose Only Cat. No. 7127-0041

MIXOR™ Vacuum Mixing System with SyringeCat. No. 7127-0020

Cat. No. Description

7127-0080 Standard Breakaway

7127-0081 Long Tapered

7127-0082 Angled

7127-0084 Revision

7127-0085 Umbrella

Catalog information – Cement accessories/Mixer components

MIXOR Pump OnlyCat. No. 7127-0042

VORTEX Cement Gun Cat. No. 7127-2001

Re-use Kit (not shown)Cat. No. 7127-0071

VORTEX Nozzles

43

MIXOR™ Pump Connector, SchraederCat. No. 7127-0050

MIXOR Pump Connector, DragerCat. No. 7127-0051

MIXOR Pump Connector, D.I.S.S.Cat. No. 7127-0052

VERSABOND™ Bone CementCat. No. 7127-1340

VERSABOND AB* Bone CementCat. No. 7127-1440 *Check for availability

PREP-IM™ Total Hip Preparation KitCat. No. 12-1010

Includes the following:2 BUCK™ Cement Restrictors 1 Femoral Canal Brush1 BUCK Disposable Inserter1 Femoral Canal Suction Absorber2 Concise Cement Sculps1 Medium Femoral Pressurizer

Cat. No. Description

91-4535 13mm

12-9418 18.5mm

12-9419 25mm

7127-9420 30mm

7127-9421 35mm

Medium Femoral PressurizerCat. No. 7127-0027

BUCK™ Cement Restrictors

44

Handpiece with Synthes Connection Cat. No. 7127-7006

Catalog information – Cement accessoriesPOWERPULSE™ Lavage SystemHandpiece with Zimmer CouplingCat. No. 7127-7000

Powerhose with Zimmer CouplingCat. No. 7127-7001

POWERPULSE Lavage Hip and Knee with SuctionCat. No. 7127-7004

POWERPULSE Lavage Hip and Knee without SuctionCat. No. 7127-7005

45

ECHELON™ Revision Instrument Set (Cat. No. ECH001)

Cat. No. Description Ref.

7136-4100 Osteotomy Guide A

7136-4002 Box Osteotome B

7136-4001 Femoral Canal Finder C

7136-4006 T-Handle (2 per set) D

7136-4015 Proximal Reamer E

7136-4007 Broach Handle (2 per set) F

7136-4012 Anteversion Handle (2 per set) G

AB

C

D

E

F

G

F

ECHELON™ Revision Starter TrayCat. No. 7136-6001

46


7135-0090 Rigid Reamer, Size 9 mm A

7135-0095 Rigid Reamer, Size 9.5 mm B

7135-0100 Rigid Reamer, Size 10 mm C

7135-0105 Rigid Reamer, Size 10.5 mm D

7135-0110 Rigid Reamer, Size 11 mm E

7135-0115 Rigid Reamer, Size 11.5 mm F

7135-0120 Rigid Reamer, Size 12 mm G

7135-0125 Rigid Reamer, Size 12.5 mm H

7135-0130 Rigid Reamer, Size 13 mm I

7135-0135 Rigid Reamer, Size 13.5 mm J

7135-0140 Rigid Reamer, Size 14 mm K

7135-0145 Rigid Reamer, Size 14.5 mm L

ECHELON™ Rigid Reamer TrayCat. No. 7136-6002


7135-0150 Rigid Reamer, Size 15 mm M

7135-0155 Rigid Reamer, Size 15.5 mm N

7135-0160 Rigid Reamer, Size 16 mm O

7135-0165 Rigid Reamer, Size 16.5 mm P

7135-0170 Rigid Reamer, Size 17 mm Q

7135-0175 Rigid Reamer, Size 17.5 mm R

7135-0180 Rigid Reamer, Size 18 mm S

7135-0185 Rigid Reamer, Size 18.5 mm T

7135-0190 Rigid Reamer, Size 19 mm U

7135-0195 Rigid Reamer, Size 19.5 mm V

7135-0200 Rigid Reamer, Size 20 mm W

AB

CD

EF

GH

IJ

KL

MN

OP

Q

R

S

T

U

V

W


47

ECHELON™ Broach TrayCat. No. 7136-6003


7136-7010 Broach, Size 10 A

7136-7011 Broach, Size 11 B

7136-7012 Broach, Size 12 C

7136-7013 Broach, Size 13 D

7136-7014 Broach, Size 14 E

7136-7015 Broach, Size 15 F

7136-7016 Broach, Size 16 G

7136-7017 Broach, Size 17 H

7136-7018 Broach, Size 18 I

7136-7019 Broach, Size 19 J

7136-7020 Broach, Size 20 K

7136-7103 Revision Trial Neck, Size 18-20 L

7136-7102 Revision Trial Neck, Size 13-17 M

7136-7101 Revision Trial Neck, Size 11-12 N

7136-7201 Trial Neck, Size 10-12, Standard Offset O

7136-7202 Trial Neck, Size 13-14, Standard Offset P

7136-7203 Trial Neck, Size 15-17, Standard Offset Q

7136-7221 Trial Neck, Size 12, Standard Offset R

7136-7222 Trial Neck, Size 13-14, High Offset S

7136-7223 Trial Neck, Size 15-17, High Offset T

7136-7204 Trial Neck, Size 18-19, Standard Offset U

7136-7224 Trial Neck, Size 18-19, High Offset V

7136-4008 Stem Inserter Frame W

7136-4011 Stem Inserter Pommel X

7136-4009 Femoral Head Impactor Y

7136-4004 Calcar Reamer Z

AB

L

M

N

W

XY

CD

EF

G

H

I

J

K

O

P

Q

R

S

T

U

V

Z

48


7136-7034 Trial Collar (2 per set) B

7136-8012 Porous Straight Stem Trial Size 12 C

7136-8013 Porous Straight Stem Trial Size 13 D

7136-8014 Porous Straight Stem Trial Size 14 E

7136-8015 Porous Straight Stem Trial Size 15 F

7136-8016 Porous Straight Stem Trial Size 16 G

7136-8017 Porous Straight Stem Trial Size 17 H

7136-8018 Porous Straight Stem Trial Size 18 I

7136-8019 Porous Straight Stem Trial Size 19 J

7136-8020 Porous Straight Stem Trial Size 20 K

7136-4014 Cemented Stem Inserter L

ECHELON Straight Stem Trial Tray Porous and CementedCat. No. 7136-6004


7136-8512 Cemented Stem Trial, Size 12 Length 175mm

M


N


O


P


Q


R

K

J

I

H

G

F

E

A D

C

B

R

Q

P

O

N

M

L


49

CD

EF

GH

IJ

KL

AB

MN

OP

U

R

ST

Q

VW

XY


7135-1900 Thin Shaft Reamer, 9mm A

7135-1100 Thin Shaft Reamer, 10mm B

7135-1110 Thin Shaft Reamer, 11mm C

7135-1115 Thin Shaft Reamer, 11.5mm D

7135-1120 Thin Shaft Reamer, 12mm E

7135-1125 Thin Shaft Reamer, 12.5mm F

7135-1130 Thin Shaft Reamer, 13mm G

7135-1135 Thin Shaft Reamer, 13.5mm H

7135-1140 Thin Shaft Reamer, 14mm I

7135-1145 Thin Shaft Reamer, 14.5mm J

7135-1150 Thin Shaft Reamer, 15mm K

7135-1155 Thin Shaft Reamer, 15.5mm L

ECHELON™ Thin Shaft Reamer TrayCat. No. 7136-6006


7135-1160 Thin Shaft Reamer, 16mm M

7135-1165 Thin Shaft Reamer, 16.5mm N

7135-1170 Thin Shaft Reamer, 17mm O

7135-1175 Thin Shaft Reamer, 17.5mm P

7135-1180 Thin Shaft Reamer, 18mm Q

7135-1185 Thin Shaft Reamer, 18.5mm R

7135-1190 Thin Shaft Reamer, 19mm S

7135-1195 Thin Shaft Reamer, 19.5mm T

7135-1200 Thin Shaft Reamer, 20mm U

7135-1205 Thin Shaft Reamer, 20.5mm V

7135-1210 Thin Shaft Reamer, 21mm W

7135-1215 Thin Shaft Reamer, 21.5mm X

7135-1220 Thin Shaft Reamer, 22mm Y

50

ECHELON™ 21-22mm Bowed Stem Trial & Reamer TrayCat. No. 7136-6007


7135-3225 Thin Shaft Reamer, 22.5mm A

7135-3230 Thin Shaft Reamer, 23mm B

7135-3235 Thin Shaft Reamer, 23.5mm C

7135-3240 Thin Shaft Reamer, 24mm D

7136-8421 Porous Bowed Stem Trial Size 21 Right E

7136-8422 Porous Bowed Stem Trial Size 22 Right F

7136-8321 Porous Bowed Stem Trial Size 21 Left G

7136-8322 Porous Bowed Stem Trial Size 22 Left H

7136-7034 Trial Collar (2 per set) I

7136-6008 300mm Bowed Cemented Stem Trial Tray J


7136-8712 Cemented Stem Trial, Size 12 Left, Length 300mm A

7136-8812 Cemented Stem Trial, Size 12 Right, Length 300mm B

7136-8714 Cemented Stem Trial, Size 14 Left, Length 300mm C

7136-8814 Cemented Stem Trial, Size 12 Right, Length 300mm D

ECHELON 300mm Bowed Cemented Stem Trial Tray Cat. No. 7136-6008

CD

E

AB

F

G

HI

J

CD

AB


51


7136-7034 Trial Collar (2 per set) A

7136-8412 Porous Bowed Stem Trial, Size 12 Right B

7136-8413 Porous Bowed Stem Trial, Size 13 Right C

7136-8414 Porous Bowed Stem Trial, Size 14 Right D

7136-8415 Porous Bowed Stem Trial, Size 15 Right E

7136-8416 Porous Bowed Stem Trial, Size 16 Right F

7136-8417 Porous Bowed Stem Trial, Size 17 Right G

7136-8418 Porous Bowed Stem Trial, Size 18 Right H

7136-8419 Porous Bowed Stem Trial, Size 19 Right I


7136-8420 Porous Bowed Stem Trial, Size 20 Right J

7136-8312 Porous Bowed Stem Trial, Size 12 Left K

7136-8313 Porous Bowed Stem Trial, Size 13 Left L

7136-8314 Porous Bowed Stem Trial, Size 14 Left M

7136-8315 Porous Bowed Stem Trial, Size 15 Left N

7136-8316 Porous Bowed Stem Trial, Size 16 Left O

7136-8317 Porous Bowed Stem Trial, Size 17 Left P

7136-8318 Porous Bowed Stem Trial, Size 18 Left Q

7136-8319 Porous Bowed Stem Trial, Size 19 Left R

7136-8320 Porous Bowed Stem Trial, Size 20 Left S

J

I

H

G

E

D

C

B

F

A

N

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L

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O

P

QR

S

ECHELON™ Bowed Stem Trial TrayCat. No. 7136-6015

Instructions for Use – English

Total Hip SystemsCAUTION: Federal law (USA) restricts the subject total hip arthroplasty devices to sale by or on the order of a physician.

Device DescriptionsTotal Hip SystemsThe Total Hip Systems consist of femoral components, modular necks, proximal sleeves, taper sleeves, acetabular components, fixation screws and pegs, hole covers, centralizers, and femoral heads. Components may be grit blasted, porous coated, hydroxyapatite (HA) coated, or HA porous coated. All implantable devices are for single use only.

MaterialsFemoral components are manufactured from cobalt chromium alloy, titanium 6Al-4V alloy, or stainless steel (SS). Femoral heads are manufactured from cobalt chromium alloy, OXINIUM™ oxidized zirconium, BIOLOX® forte alumina ceramic, BIOLOX delta alumina/zirconia ceramic, zirconia ceramic, or stainless steel. Acetabular liners are manufactured from ultra-high molecular weight polyethylene (UHMWPE), BIOLOX forte alumina ceramic, or BIOLOX delta alumina/zirconia ceramic. In the U.S., refer to the separate package insert provided with the ceramic acetabular liners. All poly acetabular components are manufactured from UHMWPE. Acetabular shells are manufactured from titanium 6Al-4V alloy or cobalt chromium (CoCr) alloy. BIRMINGHAM HIP™ acetabular cups are cobalt chromium (CoCr) alloy. The component material is provided on the outside carton label. Note: BIOLOX delta ceramic liners are not available for use in the U.S.Some of the alloys needed to produce orthopedic implants contain metallic components that may be carcinogenic in tissue cultures or in an intact organism under very unique circumstances. Questions have been raised in the scientific literature as to whether or not these alloys may be carcinogenic in implant recipients. Studies conducted to evaluate this issue have not identified conclusive evidence of such phenomenon, in spite of the millions of implants in use.

Femoral ComponentsFemoral components are available in a variety of sizes. Porous coated components are coated for biological ingrowth and are intended for use without cement. Modular femoral components are available with an oval taper to accept Smith & Nephew CoCr modular necks and/or a Morse-type taper to accept proximal sleeves. Non-porous femoral components can feature poly(methyl methacrylate) (PMMA) centralizers that help produce a uniform cement thickness.Femoral components, available with 10/12, 12/14, and 14/16 tapers, mate and lock directly with Smith & Nephew femoral heads having the same size taper. Certain femoral heads may require taper sleeves for attachment to the femoral stem taper. Refer to the table in the taper sleeve section for details.

Taper SleevesA taper sleeve may be required when mating femoral stems with specific types of femoral heads. Refer to the sleeve compatibility table for the appropriate combinations. Failure to utilize the proper sleeve to head combination may lead to implant failure and may result in revision surgery. Never place more than one taper sleeve on a femoral component, this combination will increase stresses on the implant and may lead to failure and may result in revision surgery.

Modular NecksModular necks are made from CoCr alloy and are available in a variety of configurations. The modular neck mates and locks with the oval taper of a modular femoral component on one end and the taper of a 12/14 femoral head on the other end.

Compatible Sleeve Combinations

Femoral Stem Taper

40, 44 mm Modular OXINIUM Heads

40, 44 mm Modular CoCr Heads

Modular CoCr Heads*

BH Modular CoCr Heads**

TANDEM™ CoCr & OXINIUM Unipolar Heads

14/16 OXINIUM and CoCr Heads

12/14 A A B B C -

14/16 - - - - D No sleeve required

10/12 - - - - E F

* Modular CoCr heads are made from CoCr alloy and are intended for hemiarthroplasty use in the U.S. Refer to the separate package insert provided with the components.

** BH Modular Heads are not available for use in the U.S. These heads can only be used with uncemented SYNERGY™ Femoral Stems. Sleeve Material Description/Part Numbers

A Ti-6AI-4V Ti 12/14 Modular Sleeve -4: 71344245, +0L: 71344247, +4: 71344248, +8: 71344250

B CoCr CoCr 12/14 Modular Sleeve -4: 74222100, +0: 74222200, +4: 74222300, +8: 74222400

C Ti-6Al-4V 12/14 TANDEM Unipolar Sleeve -3: 71326603, +0: 71326600, +4: 71326604, +8: 71326608, +12: 71326613

D Ti-6Al-4V 14/16 TANDEM Unipolar Sleeve +0: 126600, +4: 126604, +8: 126608, +12: 126613

E Ti-6Al-4V 10/12 TANDEM Unipolar Sleeve +4: MH0304, +8: MH0308, +12: MH0312, +16: MH0317

F Ti-6Al-4V 10/12 to 14/16 Taper Conversion Sleeve +0: MH0001, +12: MH0003

Femoral HeadsFor proper anatomic and musculature fit, cobalt chromium, stainless steel, oxidized zirconium, and ceramic heads are available in multiple neck lengths. Heads are available in 10/12, 12/14, and 14/16 tapers. Certain modular heads and unipolar heads may require taper sleeves for attachment to the femoral stem taper. Refer to the Compatible Sleeve Combinations table in the Taper Sleeves section for details. Heads are highly polished for reduced friction and wear. Femoral components and femoral heads are designed for use with any Smith & Nephew polyethylene acetabular component or polyethylene-liner, metal-backed acetabular component having an appropriately-sized inside diameter.The following BIOLOX forte ceramic heads and BIOLOX delta ceramic heads are available for use only with 12/14 taper femoral components:

BIOLOX forte Ceramic Heads Head Diameter Neck Length71332800 71330280* 526969 28 mm S/+071332804 71330284* 526970 28 mm M/+471332808 71330288* 526971 28 mm L/+871333200 71330320** 526914 32 mm S/+071333204 71330324** 526915 32 mm M/+471333208 71330328** 526916 32 mm L/+871331047 71332084*** 76539150 36 mm S/+071331048 71332085*** 76539151 36 mm M/+471331049 71332086*** 76539152 36 mm L/+8* Used with REFLECTION™ BIOLOX forte Ceramic Acetabular Liners in the U.S.** Used with REFLECTION BIOLOX forte Ceramic Acetabular Liners and R3 BIOLOX

forte Ceramic Acetabular Liners in the U.S.*** Used with R3 BIOLOX forte Ceramic Acetabular Liners in the U.S.

In the U.S., refer to the separate package insert provided with the ceramic acetabular liners.BIOLOX delta Ceramic Heads Head Diameter Neck Length

71346001 28 mm S/+071346002 28 mm M/+471346003 28 mm L/+876539160 32 mm S/+076539161 32 mm M/+476539162 32 mm L/+876539165 36 mm S/+076539166 36 mm M/+476539167 36 mm L/+876539153† 36 mm XL/+1271346004 40 mm S/+071346005 40 mm M/+471346006 40 mm L/+871330029 44 mm S/+071330031 44 mm M/+471330032 44 mm L/+8

† Not available for use in the U.S.

The following CoCr BIRMINGHAM HIP (BH) modular heads†† should be used only with BIRMINGHAM HIP acetabular cups. BIRMINGHAM HIP Modular Heads74222138 38 mm 74222140 40 mm 74222142 42 mm 74222144 44 mm 74222146 46 mm 74222148 48 mm 74222150 50 mm 74222152 52 mm 74222154 54 mm 74222156 56 mm 74222158 58 mm†† BH Modular Heads are not available for use in the U.S.

Acetabular ComponentsAcetabular components can be one-piece all polyethylene or CoCr (BIRMINGHAM HIP only), or two-piece, consisting of a titanium shell and either a UHMWPE liner, BIOLOX forte ceramic liner, or BIOLOX delta ceramic liner. For BIOLOX forte ceramic liners available for use with the REFLECTION Ceramic Acetabular System in the U.S., refer to the separate package insert provided with the components. Refer to the Warnings and Precautions section for specific information on the use of screws, pegs, and hole covers. Acetabular reinforcement and reconstruction rings are used with an all polyethylene acetabular component. Note: BIOLOX delta ceramic liners are not available for use in the U.S. Note: The 10 Mrad cross-linked UHMWPE acetabular liners may be used with metal (CoCr and SS), oxidized zirconium, BIOLOX forte ceramic heads, or BIOLOX delta ceramic heads. Note: Stainless steel heads are not available for use in the U.S.Acetabular liners are designed for use only with acetabular shells from the same product family (i.e., REFLECTION liners can only be used with REFLECTION shells; R3 liners can only be used with R3 shells). The use of other combinations may cause implant failure and may result in revision surgery.

IndicationsHip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Total hip systems may be indicated for use (i) with bone cement , (ii) without bone cement , or (iii) for use with or without bone cement. Refer to the product labeling and literature

for specific applications.The REDAPT™ Revision Hip System (formerly MDF) is intended to be used without cement. In the EU, the REDAPT Revision Hip System is indicated for revision surgery only.The R3 Acetabular System is for single use only and is intended for cementless use. Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.Some of the diagnoses listed above may increase the risk of complications and reduce the chance of a satisfactory result. Specifically, an increased risk of complications for revision surgery for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level can negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a higher likelihood of revision in younger, heavier, or more active patients. Specifically, the risk of complications is greater in obese and morbidly obese patients.

Contraindications• Conditions that would eliminate or tend to eliminate adequate implant support or prevent

the use of an appropriately-sized implant, e.g.: – blood supply limitations; – insufficient quantity or quality of bone support, e.g., osteoporosis, or metabolic

disorders which may impair bone formation, and osteomalacia; and – infections or other conditions which may lead to increased bone resorption.

• Mental or neurological conditions which may tend to impair the patient’s ability or willingness to restrict activities.

• Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.

• Skeletal immaturity.• The alumina ceramic liner is contraindicated for use with any product other than the

metal shell with the correlating inner taper geometry and the appropriately-sized alumina ceramic head. In the U.S., refer to the separate package insert provided with the ceramic acetabular liners.

• In revision surgery, inadequate proximal implant support is contraindicated. There is an increased risk of implant failure in revision cases where proximal support is not achieved, poor bone quality exists, and smaller sized implants are utilized. The lower the implant fixation point in the femur (distance from the head center) the greater the risk of implant fracture and/or re-revision.

• Morbid obesity.Contraindications may be relative or absolute and must be carefully weighed against the patient’s entire evaluation and the prognosis for possible alternative procedures such as non-operative treatment, arthrodesis, femoral osteotomy, pelvic osteotomy, resection arthroplasty, hemiarthroplasty, and others.

Adverse Events In Primary and Revision Surgery• Wear of the polyethylene, metal, and ceramic articulating surfaces of acetabular

components may occur. Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces. Higher rates of wear may shorten the useful life of the prosthesis and lead to earlier revision surgery to replace the worn prosthetic components.

• With all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to particulate wear debris. Particles are generated by interaction between components, as well as between the components and bone, primarily through wear mechanisms of adhesion, abrasion, and fatigue. Secondarily, particles may also be generated by third-body particles lodged in the polyethylene, metal, or ceramic articular surfaces. Osteolysis can lead to future complications necessitating the removal or replacement of prosthetic components.

• Failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening, bending, cracking, or fracture of implant components, which may lead to revision surgery.

• Failure of the implant porous coating/substrate interface or hydroxyapatite coating/porous coating bonding may result in bead separation or delamination, which may lead to increased third body wear and may result in revision surgery.

• Implant migration or subsidence that has resulted in revision surgery and has occurred in conjunction with compaction grafting procedures usually as a result of insufficient graft material, improper cement techniques, and/or varus stem alignment.

• Implant loosening or fracture, particularly of smaller sized or high offset implants, is more likely to occur in patients who are young, physically active, and/or heavy, which may lead to implant failure and revision surgery.

• Temporary or permanent device related noise such as clicking, squeaking, popping, grating, or grinding, which may lead to implant failure and revision surgery.

• Although rare, metal sensitivity reactions and/or allergic reactions to foreign materials have been reported in patients following joint replacement, which have required device removal.

Potential Complications Associated with Total Hip Arthroplasty Surgery, Primary or Revision• Infection, both early, post-operative superficial and early, post-operative deep wound

infection and late periprosthetic infection.• Neuropathies; femoral, sciatic, peroneal nerve, and lateral femoral cutaneous

neuropathies have been reported. Temporary or permanent nerve damage resulting in pain or numbness of the affected limb.

• Wound hematoma, thromboembolic disease including venous thrombosis, or pulmonary embolus. There may be an increased risk of thromboembolic disease including venous thrombosis with the cemented THA compared to the uncemented THA.

• Myositis ossificans, especially in males with hypertrophic arthritis, limited preoperative range of motion and/or previous myositis. Periarticular calcification with or without impediment to joint mobility can cause decreased range of motion.

• Trochanteric nonunion usually associated with early weight bearing and/or improper fixation of the trochanter, when a transtrochanteric surgical approach is used.

• Damage to blood vessels.• Accidental patient burns from cautery device. • Delayed wound healing.• Aggravated problems of the affected limb or contralateral extremity caused by leg length

discrepancy, excess femoral medialization, or muscle deficiency.

Warnings and PrecautionsPreoperative• Do not use if package is damaged. Do not use if the product sterilization barrier or its

packaging is compromised.• Contents are sterile unless package is opened or damaged. DO NOT RESTERILIZE. For

single use only. Discard any open, unused product. Do not use after the expiration date.• U.S. Federal law restricts this device to sale by or on the order of a physician.• Hazards associated with reuse of these devices include, but are not limited to, patient

infection and/or device malfunction.• Prior to use, inspect the device to ensure it is not damaged. Do not use a damaged

device.• The healthcare provider should have a full understanding of the product labeling

information including, but not limited to, the following: Instructions For Use (IFU), surgical techniques, and other relevant product materials that have been provided by the manufacturer.

• The patient should be warned of surgical risks, and made aware of possible adverse effects.

• The patient should be warned that the device does not replace normal healthy bone, that the implant can break or become damaged as a result of trauma or activity including heavy labor for occupation or recreation.

• The patient should be warned that the implant has a finite expected service life and may need to be replaced in the future. Patients should be warned that the longevity of the implant may depend on their weight and level of activity.

• The patient should be warned of the brittle nature of the ceramic components and the possibility of failure of the device leading to additional surgery in the future.

• Improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent early failure/fracture of the components.

• The surgeon should be thoroughly familiar with the implants, instruments, and surgical procedure prior to performing surgery. Certain insertion techniques may be different than those known for conventional hip systems, and are specifically designed to avoid potential implant failures.

• Do not mix components from different manufacturers unless specially approved by the manufacturer of the components. Failure to comply may result in implant failure and revision surgery. For purposes of product inter-compatibility, products manufactured and labeled by entities formerly known as Plus Endoprothetik, Intraplant, Precision Implants, and Plus Orthopedics (now Smith & Nephew Orthopaedics AG) may be considered as the same manufacturer, Smith & Nephew unless otherwise stated. Additional warnings and precautions may be included in component literature.

• Handle and store the implant components with extreme care. Cutting, bending, or scratching the surface of components can significantly reduce the strength, fatigue resistance, and/or wear characteristics of the implant system. These may induce internal stresses that are not obvious to the eye and may lead to fracture of the component. Implants and instruments should be protected from corrosive environments such as salt air during storage. Do not allow the porous surfaces to come in contact with cloth or other fiber-releasing materials, as this may compromise fixation and lead to failure.

• Allergies and other reactions to device materials, although infrequent, should be considered, tested for (if appropriate), and ruled out preoperatively. A reaction may lead to revision surgery.

• Fixation and expected longevity of components expected to be left in place at revision surgery should be thoroughly assessed. Damage to and/or disruption of the implant during revision surgery may lead to implant failure.

• Refer to medical or manufacturer literature for specific product information. Failure to follow the appropriate surgical technique may result in implant failure or revision surgery.

• Intraoperative fracture or breaking of instruments can occur. Instruments which have experienced extensive use or excessive force are susceptible to fracture. Instruments should be examined for wear or damage and proper operation prior to surgery. Failure to do so may result in injury to the surgical team and/or the patient. Single use devices should not be reused due to risks of breakage, failure, or patient infection and revision surgery.

• OXINIUM oxidized zirconium femoral heads and cobalt chrome femoral heads are designed to articulate with conventional UHMWPE or cross-linked polyethylene (XLPE) bearing surfaces. BIOLOX forte femoral heads and BIOLOX delta femoral heads articulate with conventional UHMWPE or XLPE bearing surfaces, BIOLOX forte ceramic liners, or BIOLOX delta ceramic liners. BHR resurfacing heads and BH cobalt chrome modular heads articulate with BH acetabular cups. OXINIUM oxidized zirconium femoral heads, cobalt chrome femoral heads, BIOLOX forte ceramic femoral heads and BIOLOX delta ceramic femoral heads should never articulate against metal bearing surfaces because severe wear of the metal bearing surfaces may occur. OXINIUM oxidized zirconium femoral heads and cobalt chrome femoral heads should never articulate against BIOLOX delta or BIOLOX forte ceramic liners because severe wear of the bearing surfaces may occur. Note: BIOLOX delta ceramic liners and BIRMINGHAM HIP CoCr modular heads are not available for use in the U.S.

• Select only Smith & Nephew femoral components for use with Smith & Nephew ceramic heads. The taper on the stem/neck is machined to tightly mate and lock with the ceramic head. An improperly dimensioned taper could result in disassociation or fracture of the ceramic head, and may result in revision surgery.

• Do not use Smith & Nephew 36 mm -3 heads with SL-PLUS™ Hip Stems and SLR-PLUS Hip Stems or any of the +16 heads with any PLUS Hip Stem. Use of these unapproved combinations may result in implant failure and revision surgery.

• Improper neck selection, positioning, looseness of acetabular or femoral components, extraneous bone, penetration of the femoral prosthesis through the shaft of the femur, fracture of the acetabulum, intrapelvic protrusion of acetabular component, femoral impingement, periarticular calcification, and/or excessive reaming may increase the risk of dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur, which may lead to revision surgery.

• Congenital deformity, improper implant selection, improper broaching or reaming, osteoporosis, bone defects due to misdirected reaming, trauma, strenuous activity, improper implant alignment or placement, patient non-compliance, etc. can increase risk of femoral or pelvic fractures.

Intraoperative• The general principles of patient selection and sound surgical judgment apply. The

correct selection of the implant is extremely important. The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age, activity levels, weight, bone and muscle conditions, any prior surgery and anticipated future surgeries, etc. Generally, the component with the largest cross-section which will allow adequate bone support to be maintained is preferred. Failure to use the optimum-sized component may result in loosening, bending, cracking, or fracture of the component and/or bone, resulting in revision surgery.

• Correct selection of the neck length and cup, and stem positioning, are important. Muscle looseness and/or malpositioning of components may result in loosening, subluxation, dislocation, and/or fracture of components. Increased neck length and varus positioning will increase stresses which must be borne by the stem. The component should be firmly seated with the component insertion instruments and stability verified. Failure to do so may result in implant failure and revision surgery.

• Care should be taken not to scratch, bend (with the exception of the reconstruction rings) or cut implant components during surgery. Refer to the “Preoperative” section of the Warnings and Precautions. Carefully examine the ceramic components for signs of damage that may have occurred during shipping or in prior in-hospital handling. Do not implant damaged components.

• A +12 mm or +16 mm femoral head should not be used with any small taper stems. These unapproved combinations will increase stresses which must be borne by the stem and may result in implant failure and revision surgery.

• Modular heads, modular necks, modular sleeves, and femoral components should be from the same manufacturer unless specially approved by the manufacturer of the components to prevent mismatch. Failure to comply may result in implant failure and revision surgery.

• Stainless steel heads and stainless steel stems should only be used together. Neither should be used with other metal components. These unapproved metal combinations may corrode causing implant failure and revision surgery.

• Use only REFLECTION Liners with REFLECTION Shells. Use only R3 liners with R3 shells. Failure to comply may result in implant failure and revision surgery.

• Clean and dry all taper connections prior to impacting for assembly. The modular femoral head, neck and/or sleeve components must be firmly seated on the femoral component to prevent disassociation, excess fretting wear, implant failure, and revision surgery.

• Care should be taken to position and drill the screw and peg holes to avoid penetration of the inner cortex of the pelvis, penetration of the sciatic nerve, or damage to other vital neurovascular structures. Perforation of the pelvis with screws that are too long can rupture blood vessels and cause the patient to hemorrhage. Do not place a screw in the center hole of the acetabular prosthesis. Placement of drills and screws in the anterior or medial portions of the prosthesis is associated with a high risk of potentially fatal vascular injury. Bone screws must be completely seated in the holes of the shell to allow proper locking for the acetabular component liner. If the tapered pegs need to be removed from the shell after impaction of the pegs, do not reuse the pegs or the peg shell holes. Use new pegs and different shell holes, or a new shell if necessary. Failure to comply may result in implant failure and revision surgery. REFLECTION 3-hole (SP3), multi-hole (SPM), peripheral hole (SPR), INTERFIT™ and R3 shells accept both REFLECTION spherical head screws and niversal cancellous bone screws. REFLECTION INTERFIT shells accept the modified REFLECTION screw hole covers. REFLECTION peripheral hole screws should only be used with REFLECTION SPR shells. Locking head pegs and REFLECTION locking head screw hole Covers are only for use with REFLECTION SP3. The threaded center hole in REFLECTION shells only accepts threaded hole covers, not screws or pegs. The INTERFIT threaded hole cover is only for use with REFLECTION INTERFIT, spiked and no hole shells. The REFLECTION threaded hole cover can be used with all REFLECTION and R3 shells. The R3 screw hole cover can be used with R3 and REFLECTION 3-hole shells. Refer to product literature for proper adjunctive fixation and hole cover usage. Failure to comply may result in implant failure and revision surgery.

• Modular components must be assembled securely to prevent disassociation. Prior to seating modular components, surgical debris including blood, bone, tissue, and bone cement must be cleaned from the surfaces. Debris may inhibit the component locking mechanism leading to implant failure and revision surgery.

• If the shell is to be cemented in place, remove extraneous cement with a plastic sculps tool to ensure proper locking of the liner. During liner insertion, make sure soft tissue does not interfere with the shell/liner interface. Chilling the liner reduces the impaction force required to seat the liner.

• Avoid repeated assembly and disassembly of the modular components which could compromise the critical locking action of the locking mechanism, resulting in component failure and revision surgery. Do not assemble and then disassemble the ceramic head and the metal femoral stem. This may cause damage to the locking and taper joints. Once the head is impacted, the ridges machined into the metal stem taper become deformed. If the ceramic head is removed, the metal stem taper cannot be reused with a ceramic head.

• Care should be taken to ensure proper cement mixing, an adequate cement mantle, and the complete support of all parts of the device embedded in bone cement, to prevent stress concentration which may lead to failure of the procedure. Specific cement mixing and handling instructions can be found on the cement product labeling. When the cement cures, care should be taken to prevent movement of the implant components. Failure to comply may result in implant failure and revision surgery.

• If the head is removed from a femoral component that will be left in place during a revision surgery, it is recommended that a metal head be used. Do not assemble a ceramic head on a used taper, the ceramic head may fracture from irregularities on the femoral component taper. If broken ceramic material is encountered, remove all loose identifiable fragments and thoroughly irrigate and suction the operative site.

• If components are to be left in place during a revision surgery, they should be thoroughly checked for cracks, scratches, looseness, and other signs of damage, and replaced if necessary. The head/neck component should be changed only when clinically necessary. Failure to comply may result in implant failure and revision surgery.

• Hazards associated with reuse of this device include, but are not limited to, patient infection, fracture of the device, and/or device malfunction.

• With a congenitally dislocated hip, special care should be taken to prevent sciatic nerve palsy. Note: The femoral canal is often very small and straight and may require an extra-small straight femoral prosthesis; however, a regular-sized prosthesis should be used when possible. Note: The true acetabulum is rudimentary and shallow. A false acetabulum should not ordinarily be utilized as a cup placement site for anatomical and biomechanical reasons.

• With rheumatoid arthritis, especially for those patients on steroids, bone may be extremely osteoporotic. Care should be taken to prevent excessive penetration of the acetabular floor or fracture of the medial acetabular wall, femur, or greater trochanter.

• Revision for previous arthroplasty procedures is technically demanding and difficult to exercise and has higher complication rates, as shown in literature. Increased operative time, increased blood loss, increased incidence of pulmonary embolus and wound hematoma, and a higher risk of infection can be expected with revision procedures.

Instructions for Use – English

Total Hip Systems continued CAUTION: Federal law (USA) restricts the subject total hip arthroplasty devices to sale by or on the order of a physician.

Intraoperative continuedCommon errors include misplacement of the incision, inadequate exposure or mobilization of the femur, inadequate removal of ectopic bone, improper positioning of components, or inadequate proximal support of the femoral component. Studies have indicated a higher risk of implant fatigue fracture in cases with inadequate proximal bone stock or where extended trochanteric osteotomies have been performed. In these cases, it is imperative that adjunctive reinforcement procedures such as bone grafting, cortical strut allografts, cables, and trochanteric plates are utilized to provide adequate proximal support to the femoral component. The use of larger prostheses may also reduce the risk of avoiding prosthetic fatigue fracture. Although these adjunctive reinforcement procedures may minimize the risk of implant failure, they do not ensure a predictable clinical result.

• Prior to closure, the surgical site should be thoroughly cleaned of cement, bone chips, ectopic bone, or other foreign matter. Ectopic bone and/or bone spurs may lead to dislocation and painful or restricted motion.

• Range of motion should be thoroughly assessed for early impingement or joint instability. Postoperative instability (i.e., dislocation) is a leading complication associated with revision surgery and may result in additional surgery.

• Proper positioning of the components is important to minimize impingement which could lead to early failure, premature wear, device related noise, and/or dislocation, all of which may lead to revision surgery.

• To minimize the risk of acetabular shell loosening in uncemented applications, surgeons should consider the use of orthopedic bone fixation devices such as bone screws, spikes, pegs, fins, or other bone fixation devices. To minimize the risk of loose cemented acetabular shells, care should be taken to prevent movement of the implant components while the cement cures.

• Physicians should consider component malposition, component placement, and the effect on range of motion and stability when using modular heads (with sleeves or skirts) and overhang liners.

• For computer assisted surgery systems, it is extremely important to correctly select input parameters (e.g., bony landmarks). Operators of this equipment should be familiar with the anatomy relevant to the procedure. Failure to provide proper input could cause problems such as violation of critical anatomical structures and malpositioned implants, which may lead to revision surgery.

• Trial instrumentation may be provided for the intraoperative assessment of the final implant fit. Do NOT implant trial components.

• Do not implant HA-coated devices in bone cement.• Inappropriate use of taper sleeves may lead to implant failure which may lead to revision

surgery. Select the appropriate sleeve based on the Compatible Sleeve Combinations Charts located in the Device Description section of this document.

Postoperative• Postoperative warnings, precautions, and patient care instructions presented by the

physician are extremely important. Gradual weight bearing begins after surgery in ordinary total hip arthroplasty procedures. However, with the trochanter osteotomy or certain complex cases, the weight bearing status should be individualized with the non or partial weight bearing period extended.

• Patients should be warned against unassisted activity, particularly use of toilet facilities and other activities requiring excessive motion of the hip, as they may result in subluxation or dislocation.

• Handle patients with extreme care. Support should be provided to the operative leg when moving the patient. While placing the patient on bedpans, changing dressings and clothing, and similar activities, precautions should be taken to avoid placing an excessive load on the operative leg.

• Postoperative therapy, prescribed by the physician, should be structured to regain muscle strength around the hip and to attain a gradual increase of activities.

• Periodic x-rays, prescribed by the physician, are recommended for comparison to immediate postoperative conditions to detect long-term evidence of changes in position, loosening, bending, and/or cracking of components or loss of bone. If these conditions are evident, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of early revision considered.

• If the ceramic head must be revised for any reason and the hip stem is firmly fixed, the revision should be made with a CoCr head and corresponding polyethylene liner and metal shell. If the REFLECTION Ceramic Liner requires revision, both the ceramic liner and the REFLECTION Acetabular Shell cannot be reassembled to any liner. If the R3 poly liner requires revision, and the R3 Acetabular Shell is well-fixed, a new R3 poly liner may be assembled to the existing R3 acetabular shell. If fractured ceramic material is encountered intraoperatively, remove all loose, identifiable fragments and thoroughly irrigate and suction the operative site.

• Prophylactic antibiotics should be recommended to the patient, similar to those suggested by the American Heart Association, for conditions or situations which may result in bacteremia.

• Normal daily activity may be resumed at the physician’s direction. Patients should be advised to seek a medical opinion(s) before entering potentially adverse environments that could affect the performance of the implant, such as electromagnetic or magnetic fields, including a magnetic resonance environment.

• The patient should be advised to report any pain, decrease in range of motion, swelling, fever, squeaking, clicking, popping, grating, or grinding noises, and unusual incidences. Patient reports of squeaking, clicking, popping, grating, or grinding should be carefully evaluated as they may indicate position changes in the components which may compromise the durability of the implants.

• Postoperative subluxation may result in higher wear and implant damage.

Cleaning and SterilizationCleaningRefer to the document “Instructions for care, maintenance, cleaning and sterilization of Smith & Nephew orthopaedic devices.” This document, reference number 71381339, is available from customer service or via the Smith & Nephew website.

SterilizationRefer to the product label for the method of sterilization. If not specifically labeled sterile, components are supplied non-sterile and must be cleaned and sterilized prior to surgery. Refer to the document, “Recommendations for decontamination instructions for care, maintenance, cleaning, and sterilization of Smith & Nephew orthopaedic devices,” which is available from customer service or via the Smith & Nephew website, for further information regarding the cleaning instructions and the validated sterilization procedures.

Recommended Steam Sterilization Cycle Parameters for Reusable Instruments• Dynamic Air Removal (Prevacuum) Steam Cycle:

Exposure temperature: 132°C (270°F); Exposure time: 4 minutes Exposure temperature: 135°C (275°F); Exposure time: 3 minutes Minimum drying time: Wrapped devices - 15 minutes

Containerized devices - 30 minutes• Gravity Displacement Steam Cycle:

Exposure temperature: 132°C (270°F) Exposure time: 15 minutes for instruments not in a containment device 30 minutes* for devices in a containment device Minimum drying time: 30 minutes*This sterilization cycle is not considered by the United States Food and Drug Administration (US FDA) to be a standard sterilization cycle. Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the selected sterilization cycle specifications (time and temperature).

• Immediate Use Steam Sterilization or Flash Steam Cycle: Exposure temperature: 132°C (270°F)Exposure time: Dynamic air removal (pre-vacuum): 4 minutes

For Non-US Customers• United Kingdom Steam Cycle:

Pre-vacuum CycleExposure temperature: 134°C (273°F) Exposure time: 3 minutesVacuum drying time: 30 minutes

• World Health Organization (WHO) Steam Cycle:Exposure temperature: 134°C (273°F) Exposure time: 18 minutesVacuum drying time: 30 minutes

Note: Sterilization evacuation and pulsing should be carried out in accordance with HTM 2010.

InformationFor further information on the medical devices, the information presented herein, or assistance in returning product contact Customer Service at (800) 238-7538 for calls within the continental USA and (901) 396-2121 for all international calls.

Smith & Nephew Inc. 1450 Brooks Road Memphis, TN 38116 U.S.A. Tel.: 901-396-2121 www.smith-nephew.com

Smith & Nephew Orthopaedics GmbH Alemannenstrasse 14 78532 Tuttlingen, Germany Tel.: 07462/208-0 Fax: 07462/208-135

Explanation of symbols used in labeling:H2O2 – Hydrogen peroxide sterilizationID – Inner diameterOD – Outer diameterS/+0 – Short M/+4 – Medium L/+8 – Long SO – Standard offsetH or HO – High offset

– For use with bone cement

– For use without bone cement

™Trademark of Smith & Nephew. Certain marks registered U.S. Patent and Trademark Office. All trademarks acknowledged.

Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 USA

Smith & Nephew Orthopaedics GmbHAllemannenstrasse 1478532 Tuttlingen, Germany

www.smith-nephew.com+1 800 238 7538 U.S. Customer Service+1 901 396 2121 International Customer Service

10/2014 81078790 Rev. D

81078790-D

Magnetic Resonance Imaging (MRI) SafetySmith & Nephew hip systems have not been reviewed by the FDA for safety and compatibility in the MR environment. Hip system components have not been tested for heating or migration in the MR environment. Known risks of exposing implant devices to the MR environment include displacement, torque, and radio frequency induced heating. Implant devices may also create image artifacts in MR scans.

Retrieval and Analysis of Harvested ImplantsThe most important part of surgical implant retrieval is preventing damage that would render scientific examination useless. Special care should be given to protect the implant from damage during handling and shipment. Specifically, for conventional polyethylene or XLPE, use alternative sterilization method other than steam autoclave. Follow internal hospital procedures for the retrieval and analysis of implants harvested during surgery. When handling the harvested implants, use precautions to prevent spread of bloodborne pathogens.

©2015 Smith & Nephew, Inc. All rights reserved. 02194 V2 7138-0826 REV0 03/15

Smith & Nephew, Inc.1450 Brooks RoadMemphis, TN 38116USA

Telephone: 1-901-396-2121Information: 1-800-821-5700Orders/inquiries: 1-800-238-7538

www.smith-nephew.com

™Trademark of Smith & Nephew. Certain marks Reg. US Pat. & TM Office. All trademarks acknowledged.

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