gription tf acetabular augments - …synthes.vo.llnwd.net/o16/llnwmb8/us mobile/synthes north...

GRIPTION® TF ACETABULAR AUGMENTS

DESIGN RATIONALE / SURGICAL TECHNIQUE

GRIPTION® TF ACETABULAR AUGMENT SYSTEMDESIGN RATIONALE

SURGICAL TECHNIQUE

ORDERING INFORMATION

TABLE OF CONTENTS

DePuy Synthes Joint Reconstruction GRIPTION® TF Acetabular Augments Design Rationale/Surgical Technique

Acetabular Augment Portfolio 4

System Overview 5

Advanced Material 6

Advanced Fixation 8

Advanced Instrumentation 10

Increased Compatibility 12

Treatment by Defect Algorithm 13

Key Bone Stock and Landmark Considerations 14

Acetabular Preparation 16

Implant Insertion 18

Implant Options 23

Screw Options 24

Instruments 25

Essential Product Information 28

Advanced

InstrumentationAdvanced

Fixation

Advanced

Material

GRIPTION® TF ACETABULAR AUGMENT SYSTEMFilling the gap in acetabular revision surgery

GRIPTION® TF Acetabular Augments Design Rationale / Surgical Technique DePuy Synthes Joint Reconstruction 3

DePuy Synthes Joint Reconstruction’s GRIPTION® TF Acetabular Revision System is an innovative technology for addressing bone defects in complex acetabular revision surgery. It represents the latest advances in materials, fixation, and instrumentation technologies. Combined with other elements of the PINNACLE® Hip Solutions portfolio – including the leading acetabular shell system and advanced bearing options – the result is a winning solution to help restore motion for today’s revision patient.

INTRODUCTION

DESIGN RATIONALE

4 DePuy Synthes Joint Reconstruction GRIPTION® TF Acetabular Augments Design Rationale / Surgical Technique

The GRIPTION® TF Augments are designed to act as a defect filling implant in the case of severe bone loss in the acetabulum.

Advanced geometry provides increased surface area for bone contact.

Directional screw holes engineered to maximize fixation capability. 5.5mm locking or 5.0mm non-locking screws can be utilized on the outer rim.

Screwhole cutaways designed to optimize fit with PINNACLE Shell System.

Proprietary TRUEBOND™ locking slot to help mechanically secure Augment to acetabular shell using a PINNACLE 6.5mm Bone Screw.

Tight radius inner diameter to achieve precise fit with shell.

SYSTEM OVERVIEW


AdvancedInstrumentation

AdvancedFixation

AdvancedMaterial

1.02

1.00

0.98

0.96

0.94

0.92

0.90

0.88

0.86

0.84

0.82

0.04

0.02

0.0GRIPTION® TF

Material1Trabecular Metal™

Material2

The GRIPTION® TF material is a completely porous structure made from commercially pure titanium. It provides a modulus of elasticity similar to bone, and a coefficient of friction that allows for initial scratch fit.

ADVANCED MATERIAL


Compressive Yield Strength

60

50

40

30

20

10

0GRIPTION TF

Material1Trabecular Metal™

Material3

MPa

20

15

10

5

0

GPa

GRIPTION® TFMaterial1

Trabecular Metal™ Material4

Cortical6Bone

Cancellous7

Bone



AdvancedFixation

AdvancedMaterial

TRUEBOND™ Cementless Technology*

Hybrid Fixation*Cemented

Prior to the availability of the GRIPTION® TF Augments, the only method of fixating the Augment to the shell was with bone cement. The introduction of the GRIPTION TF Augments allow surgeons to select between cementless, cemented, and hybrid options of Augment to shell fixation.

CEMENTED, CEMENTLESS, OR HYBRID FIXATION OPTIONS

* The TRUEBOND™ cementless technology and hybrid fixation is achieved using a 6.5mm PINNACLE Bone Screw from the shell to the augment.

ADVANCED FIXATION


GRIPTION® TF implants have the ability to use locking screws to fixate the Augment to the host bone. Locking screws help prevent the screw from becoming loose and backing out of the Augment. This helps eliminate the risk of compromising fixation as a result of screw migration. In addition, GRIPTION TF allows surgeons to implant diverging locking screws for even stronger fixation to the host bone.

5.5 mm Locking Screws can be utilized in the inner diameter of the augment as well as on the outer rim as shown in the image.

Note: Locking Screws should not be placed in the Truebond Locking Slot. The TRUEBOND locking slot is only compatible with a 6.5 mm PINNACLE Bone Screw.

LOCKING SCREW OPTION

The option is also available for 5.0 mm PINNACLE Non-Locking screws to be placed on the flat outer rim of the augment.

SCREW PLACEMENT

NON LOCKING SCREW OPTIONNote: Do not place non-locking screws on the inner diameter of the augment or through the TRUEBOND Locking Slot. NO screw should be placed through the TrueBond Slot directly into bone.

5.0 non-locking screw or 5.5mm polyaxial locking screw

5.5 mm polyaxial locking screw

Note: On the 10 mm thick augments the two outside holes on the outer periphery are for Threaded Headed pin placement only. Do not place screws through these two holes.

6.5 mm PINNACLE cancellous bone screw



AdvancedFixation

AdvancedMaterial

The GRIPTION TF Revision System allows surgeons to select two methods of preparing the acetabular bone with their choice of modular or finishing rasps.

The instruments for GRIPTION TF were designed to provide ease of use and consistency for the surgeon and OR team. The finishing rasps, modular rasps, and accompanying PINNACLE Cup Instrumentation allow for an increased conformity between the prepared bone and the implanted augment.

ADVANCED INSTRUMENTATION

11 DePuy Synthes Joint Reconstruction GRIPTION TF Augments Design Rationale / Surgical Technique

Finishing rasp

Half Shell Trial

Modular rasp

GRIPTION TF Augments Design Rationale / Surgical Technique DePuy Synthes Joint Reconstruction 11

100 series

Sector

Deep Profile Revision

INCREASED COMPATIBILITY

The DePuy Synthes Joint Reconstruction GRIPTION® TF Augments are compatible with the PINNACLE Hip Solutions Acetabular system. The PINNACLE Hip Solutions portfolio provides the largest selection of advanced bearing technologies. With more implant designs and choices than any competitive system, you’ll never have to compromise when meeting the individual needs of patients.

Multi-Hole

Standard Profile Revision


The Paprosky Classification is the most widely used defect classification.5

POSSIBLE SURGICAL SOLUTIONS BY DEFECT CLASSIFICATION

Type 1 Solution: PINNACLE GRIPTION® Shell

• Anterior/posterior columns are intact and supportive

• Greater than 70 percent of host bone to hemispherical shell contact

Type 2A Solution: PINNACLE GRIPTION Multi-hole/ Revision Shell

• Anterior/posterior columns are intact and supportive

• Superior migration less than 2cm

• Up to 30 percent of the shell may be uncovered superiorly

Type 2B Solution: PINNACLE GRIPTION Multi-hole/ Revision Shell Potential GRIPTION® TF Augment

• Superior migration less than 2cm

• Anterior/posterior columns are supportive

• Greater than 50 percent of host bone to hemispherical shell contact

Type 2C Solution: PINNACLE GRIPTION Multi-hole/ Revision Shell Potential GRIPTION TF Augment

• Rim is intact but distorted

• Medial wall defect and superior head center migration (<2cm)

• Teardrop is obliterated

Type 3A Solution: PINNACLE GRIPTION Multi-hole/ Revision Shell Potential GRIPTION TF Augment

• 30-60 percent of rim unsupportive

• Greater than 2cm superior migration

• Less than 50 percent of host bone to hemispherical shell contact


RADIOGRAPHIC LANDMARKS

SURGICAL TECHNIQUE

BONE STOCK CONSIDERATIONSCompletely supportive acetabulum: PINNACLE Hip Solutions Shell

Partially supportive acetabulum: PINNACLE Hip Solutions Shell with GRIPTION TF Augments

Radiographic landmarks can be helpful in assessing the acetabular bone stock. It can also be useful to order a CT scan of the area with a metal suppression technique. A CT scan will often indicate significantly more lysis than what is apparent on plain radiographs, and can also aid in determining pelvic discontinuities or loss of structural bone.

ANATOMIC LANDMARKS

1. Acetabular teardrop – integrity of medial wall and inferior portion of anterior and posterior column

2. Kohler’s line – integrity of medial wall and superior anterior column

3. Ischial lysis – integrity of posterior wall and posterior column

Using the standard DePuy Synthes Joint Reconstruction PINNACLE acetabular shell templates, the surgeon can determine the approximate size of the revision shell that may be required, including the possibility of jumbo shells (>66mm diameter), deep profile shells, or acetabular Augments. Assessing the acetabular bone stock is of great importance in helping the surgeon to anticipate the possible structural defects that may be encountered during the surgery.

PRE-OPERATIVE PLANNING AND TEMPLATINGShell OD Augment ID

50, 52 50mm

54, 56 54mm

58, 60 58mm

62, 64 62mm

66, 68 66mm

70, 72 70mm


ACETABULAR PREPARATIONOnce the acetabulum has been exposed and evaluated, preparation for the acetabular construct can begin. Start by reaming the acetabulum with an undersized reamer at a level that will restore the appropriate center of rotation. Ream concentrically with progressively larger reamers – maintaining appropriate opening abduction and anteversion. Reaming should stop when adequate rim contact has been obtained excluding the defect region.

At this point, the surgeon has 2 options for preparing the acetabular defect to accept the GRIPTION TF Augment:

• Finishing Rasp (most utilized option)

• Modular Rasp


ACETABULAR PREPARATION

SURGICAL TECHNIQUE

FINISHING RASP TECHNIQUE

Once the acetabular cavity has been prepared, place the shell trial into the prepared bed at the correct center of rotation.

Choose the appropriately sized finishing rasp that corresponds with your PINNACLE shell. Start preparing the acetabular defect by keeping the inside diameter of the finishing rasp against the outer surface of the acetabular trial. Rasps should only be utilized over the shell trial and not over the final shell implant.

Note: Take care to confirm that the connections for the Strike Plate-Handle and Power Adapter-Handle have been fully engaged. The button feature will return to it’s original height and an audible clicking noise will be apparent.

Note: Rasps can be used with Stryker® Power series 5 or 6 Reciprocating Power.

Advance the rasp slowly until the desired seating level is obtained. The rasp sizes directly match the corresponding augment trial and final implant. These rasps can be used to judge the seating of the actual implant. If it appears that there is not intimate bone contact with the rasp, increasing to the next thickness of rasp may be necessary, repeating the steps above until adequate bone contact has been obtained. Once the defect has been prepared satisfactorily, tap the appropriate GRIPTION TF Augment trial into place.

TIP: Use the threaded headed pins to stabilize the augment trial.


If the trial is stable, then the defect is appropriately prepared. If adequate bone contact is not obtained, or the trial is not stable, further preparation with larger rasps may be needed.

Tip: For improved stability when rasping, use the adjustable handle (2217-01-500). Further stability may be achieved by using screws or headed drill pins in the trial shell. Placement of the screws or headed drill pins should be considered. Select holes so that the screws or pins will lie within the safe quadrant. The safe quadrant is defined by two lines from the anterior-inferior iliac spine through the center of the acetabulum and posterior by a line from the sciatic notch to the center of the acetabulum.

MODULAR RASP TECHNIQUE

Once the acetabular cavity has been prepared, utilize the half shell trial that is undersized by 1mm from the last reamer or acetabular trial that was used. Place the trial in the prepared acetabular cavity at the correct center of rotation. Attach the modular rasp to the dovetail of the trial and advance the construct so that the rasp will prepare the defect appropriately. Starting with the smallest size rasp, prepare the defect utilizing progressively larger rasps until the defect has been satisfactorily prepared to accept the appropriate size Augment. Rasps can be used on power with the Stryker Rasping Power Adaptor (2217-01-517), or can be used by hand utilizing the Rasping Strike Plate (2217-01-516). Remove the half shell trial and insert the appropriate full hemispherical acetabular trial. The GRIPTION TF Augment trial can now be placed into the defect and can be tapped into place. If the trial is stable, the defect is appropriately prepared. If adequate bone contact is not realized or the trial is not stable, then further preparation with larger rasps may be needed.

Once appropriate stability has been obtained for the Augment trial, the definitive Augment is ready to be placed.


IMPLANT INSERTIONOnce the acetabulum and acetabular defect have been prepared to accept the acetabular shell and augment, the surgeon can decide to first place the acetabular shell and then the augment, or first place the augment and then the shell. Placing the acetabular shell prior to the augment limits access to the screw holes on the inner diameter of the augment. In addition, at the time of insertion of the shell and Augment, the surgeon should decide whether cement fixation or mechanical fixation will be utilized to join the Augment to the acetabular shell.

ACETABULAR SHELL-FIRST TECHNIQUE

After preparation of the acetabulum and accompanying defect has been completed, insert the acetabular shell in accordance with the PINNACLE Acetabular Shell system technique.

Note: Acetabular shells should be placed at a targeted 35-45 degrees of abduction and 15-20 degrees of anteversion.

Use an ARD whose center aligns with the center of a screw hole. May be helpful to mark this ARD with a pen.

The augment can be marked with a line in the center to represent the center of the slot

Align the ARD with the center line of the augment while impacting the shell, and the slot will line up with the screw hole.

GRIPTION® TF SURGICAL TECHNIQUE


ACETABULAR SHELL-FIRST TECHNIQUE, CONTINUED

A 6.5mm PINNACLE bone screw may be placed at this point. The surgeon should pay close attention to any shift in position of the shell that may occur secondary to placing and tightening down the screws. If the shell requires placement of the Augment to provide stability of the construct, tightening the screws before placing the Augment may shift the shell slightly. This may cause difficulty in placing the Augment if the acetabular defect has been prepared in a precise manner. If a shift in position of the acetabular shell is noted, the screws should be backed out slightly to allow the appropriate placement of the Augment and then re-tighten. If the shell is stable without initial screw fixation the 6.5mm PINNACLE bone screw can be placed after the Augment has been inserted.

Tip: Use the 3.8 drill bit for the 6.5mm cancellous screws.

Use the 3.8 drill bit for the 5.5mm locking screw.

If using a 5.0mm non-locking screw, use the 3.2 drill bit which is utilized with the PINNACLE Revision System.

Once the acetabular shell is in place, if Cemented or Hybrid fixation is desired, place a bead of doughy cement on the outer surface of the shell prior to placing the Augment.

The Augment inserter tip should be placed on the flat surface of the Augment in the two center holes. The Augment can then be tapped into place behind the acetabular shell and into the prepared defect.


ACETABULAR SHELL-FIRST TECHNIQUE, CONTINUED

Screw fixation of the Augment can then be performed using the 5.5mm locking or 5.0mm non-locking screws. The Threaded Headed pins can be used to help stabilize the Augment during screw insertion if necessary.

Alternatively, the surgical assistant can stabilize the Augment with the inserter tip until screw fixation is obtained.

Cementless Option:

If Truebond Cementless Technology fixation is desired, a standard PINNACLE 6.5mm bone screw can be placed through the shell and fixation slot of the Augment. Special care should be taken to ensure that the head of the screw is fully seated within the acetabular shell.

TIP: Care should be taken to ensure that the PINNACLE Screw used to attach the augment to the cup does not extend beyond the augment into bone. If the screw extends past the augment and into bone then there is the potential to create a gap between the shell and augment.

Tip: Use the 3.8 drill bit for the 6.5mm cancellous screws.

Use the 3.8 drill bit for the 5.5mm locking screws.

Use the 3.2 drill bit (in the PINNACLE Revision System) for the 5.0mm non-locking screws.

IMPLANT INSERTION CONTINUED

GRIPTION® TF SURGICAL TECHNIQUE


AUGMENT-FIRST TECHNIQUE

Following preparation of the acetabulum and accompanying defect, place the acetabular augment. Utilize the 90-degree inserter tip on the inside diameter of the Augment. The Augment can now be impacted into the defect or held in place with the inserter. Insert the threaded, headed pins through the holes in the flat face of the Augment to provide provisional fixation.

Screw fixation utilizing either 5.5mm locking or 5.0mm non-locking screws can now be performed. On the inside diameter of the Augment, only 5.5mm locking screws can be utilized. Special care should be taken to ensure that the screw heads are fully seated and flush when utilizing the inner diameter fixation holes.

NOTE: Do not attempt screw fixation through the center TRUEBOND slot directly into bone.

NOTE: Do not drill into the augment to alter the shape or add additional screw holes.

NOTE: Do not attempt screw fixation in the outer periphery of the 10mm thick augments. These are to be used for pin fixation only.

TIP: Utilize either the straight or 45- degree drills on the inner diameter screw holes


AUGMENT-FIRST TECHNIQUE, CONTINUED

Cemented Option:

If the cemented fixation option is desired, a bead of doughy cement can now be placed on the inner diameter of the Augment and the acetabular shell can be impacted in the standard fashion. A 6.5mm PINNACLE bone screw can now be used for acetabular shell fixation.

Hybrid Option:

If the hybrid fixation option will be utilized, the shell should be carefully positioned during impaction so that the fixation slot of the Augment lines up with an appropriate dome hole in the acetabular shell. The shell should be impacted utilizing the standard PINNACLE acetabular shell surgical technique. Once the shell is in position, screw fixation of the shell can be carried out. An additional 6.5mm PINNACLE bone screw may be placed through the appropriate dome hole in the shell and through the fixation slot in the Augment. Special care should be taken to ensure that this screw head is fully seated within the inside diameter of the shell.

Tip: Bone wax on the tip of the inserter may assist holding the Augment on the inserter device.


IMPLANT OPTIONS

Catalog Code Description

1217-10-150 GRIPTION TF Augment size 50/52 x 10
























GRIPTION® TF AUGMENTS


Augment Screw Options: 5.5mm Gription TF Sterile Locking Screws


121725800 5.5X25MM GRIPTION TF STE SCREW










Mechanical Screw Fixation Options: 6.5mm Cancellous Screws


121708500 PINN CAN BONE SCREW 6.5mmX8mm





Augment Screw Options: 5.0mm Cancellous Screws


125725000 5.0mm DIA TPRD HD PER SCRW 25









SCREW OPTIONS


INSTRUMENTS

Case One: Trial Case


8299-13-505 5.5mm LOCKING SCREW CADDY


2217-10-150 GRIPTION TF Augment size 50/52x10 Trial
























GRIPTION® TF INSTRUMENTSCase One: Trial Case


2366-83-000 45-Degree Angle Drill

2274-36-000 Duraloc Depth Gauge

2274-09-000 Duraloc Drill Bit 3.8 Dia 10mm

2366-84-000 3.8mm Drill Bit 25mm

2274-12-000 Duraloc Drill Bit 3.8 Dia 40mm

2366-85-000 3.8mm Drill Bit 50mm

2217-01-518 Headed Drill PINNACLE 15mm







9505-02-071 HP Power PINNACLE Driver

2217-01-501 Augment Insert Tip Top

2217-01-502 Augment Insert Tip 90 Degree

2217-01-517 Rasping Power Adaptor

2217-01-516 Rasping Strike Plate

2217-01-503 Augment Rasping Handle

2217-01-500 Augment Adjustable Handles


Case Three: Modular Rasp Case


2217-01-550 PINN AUGMENT MOD RASP 50/52






2217-01-649 HALF SHELL TRIAL 49mm






2217-01-580 PINN AUGMENT RASP +5mm OFFSET



Case Two: Finishing Rasp Case


2217-10-550 PINN AUGMENT FIN RASP 50X10


















2217-30-550 PINN AGUMENT FIN RASP 50X30






GRIPTION® TF INSTRUMENTS


IMPORTANTThis Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

INDICATIONSThe DePuy Synthes Joint Reconstruction GRIPTION TF Acetabular Augments, Buttresses and Shims are indicated for use with the PINNACLE® Acetabular Shell System, the PINNACLE® Bantam Acetabular Shell System and the PINNACLE® Revision Acetabular Shell System for total hip replacement in the following conditions: severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous hip surgery; and certain cases of ankylosis.

INTENDED USEThe porous GRIPTION TF titanium acetabular augment is affixed to the mating acetabular shell using bone cement or mechanical screw fixation. The assembled augment/acetabular shell construct is intended for cemented or cementless use.

The porous GRIPTION TF titanium shim is affixed to the mating buttress using bone cement. This porous GRIPTION TF titanium buttress is affixed to the mating acetabular shell using bone cement. The GRIPTION TF titanium buttress/shim is affixed to the bone using bone cement or mechanical screw fixation. The assembled buttress/acetabular shell construct is intended for cemented or cementless use.

CONTRAINDICATIONSAbsolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who is incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and/or 7) vascular insufficiency, muscular atrophy, or neuromuscular disease.

WARNINGS AND PRECAUTIONS• Acetabular screws are to be fully seated to assure stable fixation and to avoid interference with

the acetabular liner component.

• Perforation entirely through the pelvic bone with dome fixation screws or rim screws is to be completely avoided. Perforation through the pelvic bone with screws through the Buttress/Shim is also to be avoided. Caution is to be used when determining and selecting the length of screws to be used, as perforation through the pelvic bone with screws that are too long can cause damage to body structures (blood vessels, etc.) located on the interior side of the pelvis.

• Tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure. Each component must properly press fit into the host bone which necessitates precise operative technique and the use of specified instruments. Bone stock of adequate quality must be present and appraised at the time of surgery.

• Care is to be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress concentrations, which may lead to failure of the procedure. Complete pre-closure cleaning and removal of bone cement debris, metallic debris and other surgical debris at the implant is critical to minimize wear of the implant articular surfaces.

• Porous titanium augments and buttresses must be attached to the acetabular shells using acrylic bone cement or screw fixation. Porous titanium shims must be attached to the buttress implants using acrylic bone cement.

• Caution should be utilized when inserting screws into porous titanium products. It is recommended that a torque-limiting screwdriver be used to seat the screws.

• Acetabular shells and augments should only be used with compatible DePuy acetabular liners, femoral components, and heads.

• Care should be taken to seat the 5.5mm Locking Screws flush and not countersunk in the Augments and Buttresses.

• The 5.5mm Locking Screws are the only screws to be used in the Inner Diameter of the Augment, and must be seated flush so that there is no interference when seating the Acetabular Shell.

• To mechanically affix the Acetabular Shell to the Augment, only a 6.5mm PINNACLE Bone Screw is to be used through the TRUEBOND™ Slot in the Augment’s Inner Diameter. Care should be taken to ensure an appropriate length of screw is used so that it does not go through the construct into the bone.

• No screw is to be used in the TRUEBOND™ Slot directly into bone to fixate the Augment.

• 6.5mm PINNACLE Bone screws are not to be used to fixate the Augment to the bone in any of the screw holes available. Only the 5.0mm Non-Locking Peripheral Screws and 5.5mm GRIPTION TF Locking Screws are to be used in the Augments.

• 6.5mm PINNACLE Bone screws are only acceptable in the two larger, distal screw holes of the Buttress implant, while the 5.0mm Non-Locking Peripheral Screws and the 5.5mm GRIPTION TF Locking Screws are acceptable in the proximal four screw holes.

• The following conditions tend to adversely affect hip replacement implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, history of infections, severe deformities leading to impaired fixation or improper positioning, tumors of the supporting bone structures, allergic reactions to materials, tissue reactions, and disabilities of other joints.

ADVERSE EVENTSThe following are the most frequent adverse events after hip arthroplasty, change in position of the components, loosening of components, wear or fracture of components, dislocation, infection, peripheral neuropathies, tissue reaction.

REFERENCES1. Data on file, DePuy Orthopaedics, Inc, Warsaw, IN

2. Zhang Y, Ahn PB, Fitzpatrick DC, Heiner AD, Poggie RA, Brown TD. “Interfacial frictional behavior: cancellous bone, cortical bone, and a novel porous tantalum biomaterial.” J Musculoskel Res. 1999;3(4):245-251.

3. Krygier JJ, Bobyn JD, Poggie RA, et al. “Mechanical characterization of a new porous tantalum biomaterial for orthopaedic reconstruction.” Proc SIROT (International Research Society of Ortho-paedic Surgery and Traumatology). Sydney Australia, 1999.

4. http://www.zimmer.com/z/ctl/op/global/action/1/id/9193/template/MP/prcat/M6/prod/y

5. Paprosky, W.G., P.G. Perona and M.J. Lawrence. “Acetabular Defect Classification and Surgical Re-construction in Revision Arthroplasty: A 6-Year Follow-Up Evaluation.” The Journal of Arthroplasty 9(1),1994:33-44.

6. Reilly, DT, Burstein, AH, Frankel, VH, “The elastic modulus for bone”, J. Biomechanics, V7, pp 271-275, 1974

7. Baohua Li, Richard M Aspden, “Mechanical and material properties of the subchondral bone plate from the femoral head of patients with osteoarthritis or osteoporosis” Annals of the Rheumatic Diseases 1997; 56:247 -254

DEPUY GRIPTION® TF ACETABULAR AUGMENT SYSTEM - ESSENTIAL PRODUCT INFORMATION

DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46582T. +1 (800) 366-8143

www.depuysynthes.com

© DePuy Synthes Joint Reconstruction, a division of DOI 2013. All rights reserved. 0612-04-511 (Rev. 3) 11/13 1.5M

Limited Warranty and Disclaimer: DePuy Synthes Joint Reconstruction products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA Law restricts these devices to sale by or on the order of a physician.

Not all products are currently available in all markets.

gription tf acetabular augments - …synthes.vo.llnwd.net/o16/llnwmb8/us mobile/synthes north...

Documents