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Solar® Total Shoulder SystemUpper Extremity Surgical Protocol

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Table of Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Patient Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Capsulotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Humeral Head Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Glenoid Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Keeled Glenoid Component Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Postoperative Care, Indications, Contraindications, Precautions, Warnings andAdverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Robert H. Bell, M.D.Chief, Shoulder ServiceSt. Thomas/Summa Health Systems and Crystal Clinic Akron, Ohio

Peter M Bonutti, M.D.Assistant Clinical ProfessorUniversity of ArkansasDirector–Apogee Medical ResearchPrivate Practice–Bonutti OrthopaedicClinicEffingham, Illinois

Hugh B. Morris, M.D.Chairman–Department of OrthopaedicSurgeryFlorida Hospital, OrlandoClinical Instructor–AdultReconstructionORMC Residency Program, Orlando,FloridaReconstructive Hip and Knee SurgeonJewett Orthopaedic Clinic, Winter Park,Florida

Michael D. Mason, D.O.Staff Surgeon New England Baptist HospitalNew England Bone & Joint Institute Assistant Professor of OrthopaedicSurgeryBoston University School of MedicineBoston University Medical CenterBoston, Massachusetts

Paul Naylor, M.D., Ph.D.Tennessee Orthopaedic ClinicKnoxville, Tennessee

Gerald Rosenberg, M.D.Chief, Upper Extremity ServiceOhio Orthopaedic InstituteGrant Medical CenterColumbus, Ohio

This surgical protocol was compiled in conjunction with:

Stryker would also like to thank the above surgeons for their assistance in the development ofthis protocol.

Solar® Total Shoulder SystemUpper Extremity Surgical Protocol

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TechTip*A true A/P and axillary view (Grashey)radiographic would be helpful in determining the true glenohumeral joint space.

IntroductionHemi and Total Shoulder Arthroplasty have proven to be successful procedures for numerous forms of arthritis of theglenohumeral joint. Due to advances inimplant and instrumentation designs, alongwith surgical technique, success rates equalthose of hip and knee implants and its application has grown steadily in recentyears.

The Solar® Total Shoulder System wasdesigned to address the most commonarthritic disorders affecting the shouldersuch as rheumatoid, osteo, and post-traumatic arthritis, avascular necrosis and various fractures of the proximal humerus.In most cases of disease involving both thehumeral head and the glenoid, with anintact rotator cuff, optimal pain reliefand function can be achieved with a total shoulder arthroplasty. In cases where thecuff is deficient and/or the disease processinvolves only the humeral head, considera-tion may be given to a hemi-arthroplasty.

Preoperative templating is imperative and assessment for candidates of shoulderarthroplasty must include radiographicstudies including an anteroposterior,lateral scapular, Grashey* and axillary view. Additional studies, such as MRI, CTscan and arthrography may be beneficial to assess the integrity of the rotator cuff,deformation of the humeral head and glenoid deformation.

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Patient PositioningFor standard shoulder arthroplasty, thepatient is positioned in a semi-Fowler beachchair position.* The back is flexed 30 to 45°,the legs are padded and bent. [Image 1] Thepatient’s shoulder is brought to the edge ofthe table to allow full extension of the arm,thus affording exposure of the humeralshaft. A half liter IV bag or surgical towelsare placed beneath the involved scapula toimprove exposure of the articular surface.[Image 2]

The head is stabilized with a donut andtaped in position, to avoid movement during the procedure. Ideally, anesthesiashould be brought to the contralateral side of the table to allow full access to thesurgical field.

Image 1

TechTip*Consideration may be given to a commercially available beach chair positioner.

Image 2

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ApproachFor most cases, an extended deltopectoralincision will be adequate to allow exposureto all involved structures. This begins 3-4cm medial to the acromioclavicular joint coursing distally over the coracoidprocess and along the deltopectoral fold.You will note that the cephalic vein is medial to the coracoid. [Image 3] In cases ofhemi-arthroplasty alone, a limited exposurecoming from coracoid process distally for a length of 8-10cm should allow adequateexposure. With the incision marked, a localanesthetic with Epinephrine may be injectedinto the subcutaneous tissue to limit skinbleeding. The incision is then taken downthrough subcutaneous tissue to the deltopectoral interval. The cephalic vein is identified and taken laterally with the deltoid. [Image 4]

Image 3

Cephalic Vein

Image 4

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Image 6

A self-retaining or Richardson type retractormay be placed beneath the pectoralis medially and the deltoid laterally. [Image 5]The conjoined tendons, as they originatefrom the coracoid process, are identified and the interval deep to the tendons andsuperficial to the subscapularis is developedby finger dissection. The musculocutaneousnerve may be palpated beneath the conjoined tendon. The medial retractor isrepositioned in this interval. It is importantto keep the blade superior so as to avoid any injury to the musculocutaneous nerve.A blunt retractor is then passed superiorlybeneath the coracoacromial ligament andacromion and superficial to the rotator cufftendons. This allows additional exposure ofthe rotator interval and the anterior capsule.[Image 6]

Image 5

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Image 7

Image 8

Biceps Tendon

Pectoralis

Incision throughSubscapularis

Axillary Nerve

Deltoid

At this point, it is advisable to palpate and,if possible, visualize the axillary nerve as itcourses along the superficial surface of thesubscapularis down into the axillary foldinferiorly. [Image 7] By means of additionalexternal rotation and abduction, many ofthe capsular structures will be brought laterally, therebyprotecting the axillary nerve during capsular release. If there isexcessive tension on the pectoralis major,the proximal two-thirds may be released atthis point using electrocautery. [Image 8]

Furthermore, if excessive tension is presenton the deltoid, a small portion of its tendi-nous insertion in the humerus distally maybe released with electrocautery in a similarfashion.

TechTipExternal rotation with abduction lets the axillary nerve fall away and be protected.

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Image 9

Traction Sutures

Pectoralis Major

Deltoid

Subscapularis

Image 10

CapsulotomyPrior to performing the anterior capsulotomy for exposure, the surgeonshould determine the amount of passiveexternal rotation available given the degreeof soft tissue contracture or bony deformity.If the patient has less than 20° of externalrotation passively, prior to capsular release,consideration should be given to performinga coronal Z-plasty lengthening of the anteriorstructures*. In most cases, a full thicknesscapsulotomy releasing both subscapularisand capsule simultaneously may be per-formed for exposure. The vertical limb of the capsulotomy begins 1.5cm to 2cmmedial to the biceps tendon. This runs from the rotator interval, superiorly to theinferior margin of the subscapularis tendondistally. A horizontal limb, both superiorlyand inferiorly, is then created and tractionsutures are placed. [Image 9] In most casesof arthritis of the glenohumeral joint,osteophytic spurring on the inferior portionof the humeral head will result in capsularshortening, loss of external rotation, andwill necessitate release to allow exposure ofthe humeral head. This is best accomplishedby placing a retractor within the capsule atthe inferior margin of the humeral head,externally rotating the arm, adducting andreleasing that capsule intra-articularly, thusavoiding injury to the extracapsular axillarynerve. [Image 10]

Inferior Margin ofHumeral Head

TechTip*An evaluation to determine whether anterior or posterior osteophytes are precluding motion should be conductedprior to performing a coronal Z-plasty.

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Image 12

Z-Plasty Lengthening for Internal Rotation ContractureIn cases of internal rotation contractures of the shoulder, a coronal lengthening of the anteri-or subscapularis and capsule will provide an increase in external rotation postoperatively.The subscapularis is longitudinally dissected off the underlying tuberosity at the level ofand immediately adjacent to the biceps tendon, a distance of approximately 1 to 2cm.[Image 11] As this moves medially, the arm is externally rotated to allow additional exposureof subscapularis and capsular interval. Having brought this to 1 to 2cm medially, a verticalcapsulotomy is made, thereby exposing the humeral head. At the time of closure, the mediallimb of the subscapularis is repaired to the lateral margin of the capsule, thus lengthening the anterior capsule 1 to 2cm and increasing external rotation by 20°–30°. [Image 12]

Image 11

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90°

30 – 40°

Image 13a

Image 13

Humeral Head ResectionThis step is critical in determining the orientation of the humeral head to the \glenoid. Furthermore, the extent ofosteophytes, loose bodies, and humeral head deformation needs to be determinedpre-operatively with templating and radiographic studies. With the capsulotomycomplete and the humeral head deliveredfor visualization, the articular surface needsto be defined. This may require the removalof osteophytes inferiorly and anteriorly todetermine the level of head resection. Inmost cases, the humeral component shouldbe set in approximately 35°–40° of retrover-sion.* There are a number of techniquesthat may be employed to achieve this retroversion. By flexing the elbow 90° andexternally rotating the arm 30°–40°, thehumeral head cut is made at right angles to the plane of the shaft and head, therebyachieving 30-40 degrees of retroversion.[Images 13 & 13a]

TechTip*In cases of anterior glenoid erosion as in Rheumatoid patients, increase retroversion prior

to resection. In cases of posterior glenoid erosion as in osteoarthritic patients, decrease

retroversion prior to resection.

45°

Image 14

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Once the margin of the articular surface isdetermined, the humeral resection guide isplaced on the long axis of the shaft with thearm in 30°– 40° of retroversion. The angle of resection (45°) is marked and the humeralcut is initiated.* The guide can be removedand the cut is completed; any residual osteo-phytes are resected. It is recommended thatthe resected head be saved for later compari-son and sizing of the modular head.[Image 14]

TechTips•Care should be taken to protect the biceps tendon and rotator cuff insertion with a smallHohman or Crego retractor during head resection.

•To avoid cutting through the posterior capsule, complete the cut with an osteotome.

•Don’t cut too steep an inclination. This would lead to tuberosity impingment.

*

Image 15

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Glenoid Preparation PeggedComponentPreoperative glenoid assessment is necessaryvia axillary view,x-ray or CT scan to deter-mine the presence of defects such as exces-sive wear, intraosseous cysts, or previousfractures. If significant, any of these mayrequire grafting. By means of gentle abduc-tion, external rotation and slight extension,the humeral shaft is brought posterior and a retractor is placed about the posterior lipof the glenoid. Similarly, a fork retractor isplaced on the anterior rim of the glenoid tobring the capsule out of the way. Remaininglabral tissue is excised and the margins ofthe glenoid are defined. [Image 15]

In cases where residual glenoid cartilage is present, a curette is used to remove the cartilage then the spherical reamer is used to prepare the glenoid face (not fossa).[Image 16]

Spherical Reamer

Angled Driver

Image 16

TechTipsGlenoid exposure can be a difficult part of total shoulder arthroplasty.The following represent suggestions for improving glenoid exposure:

•Complete release of metaphyseal capsule anteriorly and posteriorly.

•Excision of inferior humeral osteophytes and release of the posterior capsule using a blunt periosteal elevator.

•Resection of posterior humeral osteophytes.

•Release by blunt technique the posterior capsule as it attaches to the posterior aspect of the glenoid.

TechTipTo mark glenoid peg holes, use cautery to

score the surface through the brown sizing

guide. Then create starter hole with burr.

Then drill. Finish all holes with hand chuck

to make sure pegs have bottomed out.

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Universal Drill / Driver

Forked AnteriorRetractor

Glenoid Drill Guide

Posterior GlenoidRetractor

Image 18

Superior/Inferior Axis

Anterior/PosteriorAxis

Image 17

After glenoid sizing is completed with thesurface trials, the superior/inferior and anterior/posterior axis is marked. [Image17] Using these markings as reference, theappropriate size drill guide is centered onthe glenoid. The superior drill hole is pre-pared first, using the universal drill/driver.[Image 18]

The drill guide is reversed and the end withthe superior post is inserted into the drilledhole. In similar fashion, the inferior and,in the case of the two larger glenoid compo-nents, the anterior and posterior drill holesare made.

Catalog No. Description Use

5900-2081 Small Prepare peg holes anterior and posterior on large glenoid components

5900-2082 Large Prepare superior and inferior peg holes

5900-2084 Starter Drill Starter drill for peg holes

Drill Bits

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Image 20

Cement Delivery System

Image 19

Glenoid Trial

Inferior Peg isinserted first

Glenoid Pusher

Glenoid Component

Pegged Glenoid Placement A trial reduction is then performed to makecertain that there is a uniform seating of theglenoid component and that none of thepegs are bottoming out. Furthermore, eachof the peg holes is checked to make certainthat there is no break in the cortical shell.[Image 19] In preparation for cementation,small pledgets of Gelfoam™ impregnatedwith thrombin are placed into each of thedrill holes for hemostasis. A single batch of polymethylmethacrylate is mixed, theGelfoam™ is removed and each of the holes is pressurized using a cement deliverysystem. [Image 20] The implant is thenplaced and held by using the glenoid pusheror thumb until completion of polymeriza-tion. [Image 20a] All excess cement aboutthe glenoid margin is removed.

TechTipFor hemostasis of glenoid peg or keel holes–pack with epinephrine–soaked pledget

sponges then drysponge then cement. Alternatives can be gelfoam or

thrombin.

Image 20a

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Image 21

Image 22

Image 23

Keeled Glenoid Preparation Preoperative glenoid assessment is necessaryto determine the presence of defects such asexcessive wear, cysts, or previous trauma. Ifsignificant, any of these may require graft-ing. By means of gentle abduction, externalrotation and slight extension, the humeralshaft is moved posteriorly and a posteriorglenoid retractor is placed on the glenoidrim. Similarly, an anterior glenoid retractor is placed on the anterior rim of the glenoid tobring the capsule out of the way. Remaininglabral tissue is excised and the margins of theglenoid are defined.

In cases where residual glenoid cartilage, or a non-uniform glenoid surface is present,a spherical reamer is used to prepare the glenoid fossa and provide a uniform surfacefor instrumentation and implant placement.The glenoid fossa is sized using surface templates. [Image 21] When the appropriatecoverage and size has been determined, amatching spherical reamer is then used to prepare the surface. [Image 22] Thepreparation is then checked with the surfacetemplates to ensure a proper curvature hasbeen achieved.

The appropriate sized keeled glenoid guide is located on the glenoid fossa and thepreparation is then marked using methyleneblue or electrocautery. [Image 23] Thekeeled glenoid guides are in left and rightconfigurations. The slot in the guide ismarked with a line for the correspondingsized keel’s width and length. The guideallows for a 1mm cement mantle. If a largercement mantle is required, the preparationmay be opened in a similar fashion. Thekeeled guide is then removed and the boneisprepared using a high speed burr or similarinstrument.

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Keeled Glenoid Placement The appropriate sized keeled glenoid trial is then introduced in the preparation and atrial reduction is performed to make certainthere is a uniform seating of the componentand that the keel is not bottoming out.[Image 24] In preparation for cementation,small pledgets of Gelfoam™ impregnatedwith thrombin are placed into the glenoidvault for hemostasis. A single batch of poly-methylmethacrylate is mixed, the Gelfoam™is removed and the preparation is pressur-ized using a cement delivery system. [Image25] The implant is then placed and helduntil polymerization is complete. [Image 26]All excess cement about the glenoid marginis removed.

Image 24

Image 26

Image 25

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Image 27

Quick Release T-Handle

Reaming Depth of Long Stem Prosthesis

Reaming Depth of PrimaryProsthesis

Bicipital Groove

Humeral Canal Preparation Reaming: A blunt bone hook is placed within the intramedullary canal and gentlypulled laterally to deliver the humerus anterior to the glenoid. Retractors are placedbeneath the rotator cuff tissue superiorlyand medially to provide adequate exposureof the canal for reaming. Reaming beginswith bullet-tip straight reamers. Placementshould be somewhat lateral and just posteriorto the bicipital groove. This will allow forappropriate position within the canal.Reaming should be performed manuallyusing the quick release T-handle and be progressive in size until friction is felt as the reamer contacts cortical bone. Reamingdepth into the canal is to the top of the cut-ting flutes for a primary prosthesis. If a longstem prosthesis is indicated, reaming depthis to the circumferential groove positioned at the top of the reamer shaft. [Image 27]Note that the last reamer size used willmatch the distal size of the implant to beused in a pressfit application.

TechTipIt is important not to let the coracoid/conjoined tendon crowd posterior humeralmetaphysis and force your canal entry tooanterior. IM entry point should be slightly(2mm) posterior over metaphysisand valgus.

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Image 29

Trial Head

Humeral BroachSeated to Groove

Image 28

CircumferentialGroove

Broach Handle

Thumb Release

Humeral Broach

Broaching: When reaming is completed,progressive sizing of the canal with humeralbroaches is performed. The broach isattached to the quick release broach handleusing a grooved trunnion. The broach andhandle will lock together with the lateralkeyway and can be disengaged by the thumb lever. Impaction with a mallet shouldbe performed with careful attention toensure that the lateral margin of the broachis oriented just posterior [5–10mm] to thebicipital groove. This will incorporate theappropriate degree of retroversion. Thebroach should be seated to the circumferen-tial groove around the proximal section. Donot seat the broach beyond this line. [Image28] The last broach used for reaming can beleft in place and modular head trials can betested. [Image 29]

TechTipThe humeral head height should be at orslightly superior to the greater tuberosityheight.

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Image 30

Image 30A

Image 31

Fin Cutter

Anterior/ Posterior Fins

Lateral Fin Aligns withCanal Preparation

Modular Head Selection: The sizing ofthe modular head is important for success ofthis procedure. The previously resected headis compared with the modular trial head todetermine both width and height. When aglenoid is used, this lateralizes the joint lineso the humeral head height will be 4mm less than the resected head. [Images 30–30A]Consideration must be given to head defor-mity and rotator cuff tensioning. The idealmodular head should achieve the following:1) proper tensioning of the rotator cufftendons; 2) good match to anterior/posteriorhumeral width; 3) top of the modular headequal to or slightly superior to greatertuberosity; 4) enables 50% translation of thehumeral head on the glenoid both anteriorlyand posteriorly; 5) enables internal rotationwith forearm across abdomen, and 30–40°external rotation.

Fin Cutter: With humeral stem size chosen, the fin cutter is now introduced.Paying careful attention to orientation, thelateral fin of the fin cutter should line upwith the path cut by the humeral broach.Final version will be established when theanteroposterior fins of the cutter are seatedflush to the humerus. Only one fin cutterneeds to be introduced; which should matchthe last size of broach and reamer used.[Image 31]

TechTipsThe following criteria should be met if appropriate head size has been achieved:

•Internal rotation of the arm with the elbow flexed 90° to the abdomen withoutundue tension on the posterior capsule.

•External rotation to 40°–45° while being able to bring the anterior capsular structures back to their original site of release.

•External rotation to 90° without dislocation of the humeral head on the glenoid.

•50% translation of the humeral head on the glenoid both anteriorly and posteriorly with a slight inferior translation.

•The height of the modular head should be at or greater than that of the greatertuberosity.

•Additionally, inspect glenoid to see if you need to alter degree of retroversion.

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Image 32

Image 33

Humeral Component

Humeral Component PlacementA decision is made regarding cementationonce both humeral head and modular headimplant sizes have been determined. In mostcases, a pressfit of the humeral componentwill be possible. If there is a question ofthe adequacy of the fit or the quality of thecortical bone, cementation is a viable optionwith a move to a smaller sized humeralcomponent.

Cement Application: After removal ofthe humeral broach, the canal is thoroughlycleansed and dried. The humeral componenttwo distal sizes smaller than the last sizehumeral broach and fin cutter used corre-spond to the correct cemented stem size.[Image 32] Varying cement techniques canbe utilized per patient indications. The component is introduced into the canalusing the stem impactor which is placedover the trunnion and into the version holelocated lateral to the trunnion. Continue tointroduce until final placement is achieved.Be sure to remove any excess cement. [Image33]

Humeral Impactor

Cemented Application

Implant Distal Cylindrical Reamer Broach Fin CutterCatalog # Size Catalog # Catalog # Catalog #

5351-4103 7mm 5900-6009 5900-7105 5900-8105

5351-4104 8mm 5900-6010 5900-7107 5900-8107

5351-4105 9mm 5900-6011 5900-7107 5900-8107

5351-4106 10mm 5900-6012 5900-7109 5900-8109

5351-4107 11mm 5900-6013 5900-7109 5900-8109

5351-4108 12mm 5900-6014 5900-7111 5900-8111

5351-4109 13mm 5900-6015 5900-7111 5900-8111

5351-4110 14mm 5900-6016 5900-7113 5900-8113

5351-4111 15mm 5900-6017 5900-7113 5900-8113

Image 35

Humeral Impactor

Humeral Component

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NOTE: When using a long stem prosthesis, use the same sequence.

Image 36

90°

Pressfit Application: After removal of the humeral broach, the correct sizedimplant [Image 34] is inserted into thehumeral canal. Attention must be paid toversion and to aligning the fins of the pros-thesis with those of the humeral canal. Finalseating of the implant is achieved using thestem impactor as mentioned above. [Image35] As with either application, trial headsmay again be used to evaluate range ofmotion adequacy, soft tissue tensioning and to check for impingement.

Humeral Bearing Head Attachment:Thoroughly clean and dry the trunnion onthe humeral component. Place the bearinghead on the trunnion and secure it in placeusing the humeral head impactor and a mallet. Several sharp mallet blows are usedto seat the head. Be sure the angle of thedriver is in line with the axis of the trunnion(90° to collar face). [Image 36]

90°

Pressfit Application

Implant Distal Cylindrical Reamer Broach Fin CutterCatalog # Size Catalog # Catalog # Catalog #

5351-4103 7mm 5900-6007 5900-7103 5900-8103

5351-4104 8mm 5900-6008 5900-7105 5900-8105

5351-4105 9mm 5900-6009 5900-7105 5900-8105

5351-4106 10mm 5900-6010 5900-7107 5900-8107

5351-4107 11mm 5900-6011 5900-7107 5900-8107

5351-4108 12mm 5900-6012 5900-7109 5900-8109

5351-4109 13mm 5900-6013 5900-7109 5900-8109

5351-4110 14mm 5900-6014 5900-7111 5900-8111

5351-4111 15mm 5900-6015 5900-7111 5900-8111

5351-4112 16mm 5900-6016 5900-7113 5900-8113

5351-4113 17mm 5900-6017 5900-7113 5900-8113

Image 34

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Repair of CapsulotomyThe shoulder is reduced and stability is confirmed. The anterior capsulotomy andsubscapularis are repaired anatomically withnon absorbable suture material. Attentionshould be directed not only to the anteriorcapsule, but also the rotator interval. In casesof a coronal Z-plasty, the lateral margin ofthe subscapularis is repaired to the residualstump of lateral capsule [reference Image11]. The deltopectoral interval is allowed tore-approximate itself and is loosely repairedwith 3.0 absorbable suture material. Sub-cutaneous and skin layers are closed with 3.0 and 4.0 absorbable sutures. Suctiondrainage may be used as needed.

Immediate Post-Operative CarePatients may be placed in a cold therapydevice for postoperative cryotherapy and a simple sling. Physical therapy is initiatedon the first or second postoperative day, aspatient comfort allows. Therapy should consist of gentle assisted forward elevationand external rotation as well as pendulumexercises. Patients may be discharged on the second or third postoperative day andstarted on a formal physical therapy program.

TechTipClosure: The subscapularis can be repaired to the anterior humeral neck through drill holes

if more external rotation is needed.

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DescriptionStryker® shoulder prostheses consist ofboth humeral and glenoid components.Depending on design, the humeral compo-nents may be used in conjunction with a glenoid component for conventional totalshoulder arthroplasty or to articulate directlywith the anatomic glenoid in a hemi-shoulder application. The components areintended for implantation within the humeraland glenoid fossa preparations in cementedor cementless applications dependent upondevice design (consult component packagelabeling for application restrictions).

Humeral Components: The humeral component is available in modular design.The selection of the appropriate humeralcomponent is dependent upon the type ofarthroplasty intended, bone geometry andthe type of fixation. The modular humeraldesign consists of both humeral stem andinterchangeable humeral head components.The modular head components are availablein diameters ranging from 40mm to 55mmin 5mm increments and in selected thick-nesses ranging from 12mm to 34mm.

Glenoid Components: The glenoid component consists of an all-polyethylenedesign available in an array of sizes. Each size has a thickness of 4mm.

Materials:•ASTM F-1537 Cobalt chromium alloy

Humeral heads,

•ASTM F-90 Cobalt chromium alloyGlenoid x-ray marking wire

•ASTM F-136 Titanium 6AL-4V ELIalloyHumeral stem component

•ASTM F-648 ultra-high molecularweightGlenoid component polyethylene (UHMWPE)

Indications• Aseptic necrosis of the humeral head.

• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.

• Proximal humeral fracture and/or dislocation.

• Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achievesatisfactory results.

Contraindications• Any active or suspected latent infection in

or about the shoulder joint.

• Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

• Bone stock compromised by disease,infection or prior implantation which cannot provide adequate support and/orfixation to the prosthesis.

• Skeletal immaturity.

• Absent, irreparable or non-functioning rotator cuff and other essential muscles.

• Patients whose anticipated activities would impose high stresses on the prosthesis andits fixation.

• Obesity. An overweight or obese patient can produce loads on the prosthesis whichcan lead to failure of fixation of the device or to failure of the device itself.

Precautions• Before clinical use, the surgeon should

thoroughly understand all aspects of thesurgical procedure and limitations of thedevice. Patients should be instructed in the limitations of the prosthesis, including,but not limited to, the impact of excessiveloading through patient weight or activity,and be taught to govern their activitiesaccordingly. If the patient is involved in an occupation or activity which includessubstantial walking, running, lifting, ormuscle strain, the resultant forces can causefailure of the fixation, the device, or both.The prosthesis will not restore function tothe level expected with normal healthybone, and the patient should not haveunrealistic functional expectations.

• Appropriate selection, placement and fixation of the shoulder components arecritical factors which affect implant servicelife. As in the case of all prosthetic implants,these components are affected by numerousbiologic, biomechanic and other extrinsicfactors, thereby limiting the service life anddurability of the product. Accordingly, strictadherence to the indications, contraindica-tions, precautions and warnings for thisproduct is essential to potentially maximizeits service life.

• Care must be taken to protect the compo-nents and any polished bearing surfacesfrom being marred, nicked or notched as a result of contact with metal or abrasiveobjects.

Utilization and Implantation• The recommended trial components

should be used for size determination,trial reduction and range of motion evaluation, thus preserving the integrity of the actual implants and their sterilepackaging.

•Radiographic templates are available toassist in the preoperative prediction ofcomponent size and style.

•The Stryker Surgical Protocols provideadditional procedural information.

Postoperative Care, Indications, Contraindications, Precautions, Warnings and Adverse Effects

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Warnings•Discard all damaged or mishandledimplants.

•Never reuse an implant, even though it mayappear undamaged.

•Polished bearing areas must not come incontact with hard or abrasive surfaces.

•Bearing areas must always be clean and freeof debris prior to assembly.

•Contouring and bending of an implant mayreduce its fatigue strength and cause failureunder load.

•Care should be taken not to cut throughsurgical gloves when handling anysharpedged orthopaedic device.

•Stryker strongly advises against the use ofanother manufacturer’s component withany Stryker shoulder component. Any suchuse will negate the responsibility of Strykerfor the performance of the resulting mixedcomponent implant.

•Removal of an unloosened implant mayrequire the use of special instruments to disrupt the interface at the implant surface.

•Return all packages with flaws in the sterilebarrier to the supplier. Do not resterilize.

Adverse Effects•While the expected life of total shoulderreplacement components is difficult to estimate, it is finite. These components aremade of foreign materials which are placedwithin the body for the potential restorationof mobility or reduction of pain. However,due to the many biological, mechanical andphysicochemicalfactors which affect thesedevices, but cannot be evaluated in vivo, thecomponents cannot be expected to indefi-nitely withstand the activity level and loadsof normal healthy bone.

•Dislocation of the total shoulder prosthesiscan occur due to inappropriate patientactivity, trauma or other biomechanicalconsiderations.

•Loosening of total shoulder componentscan occur. Early mechanical loosening mayresult from inadequate initial fixation, latentinfection, premature loading of the prosthesisor trauma. Late loosening may result fromtrauma, infection, biological complications,including osteolysis, or mechanical problems,with the subsequent possibility of bone erosion and/or pain.

•Fatigue fracture of total shoulder compo-nents has occurred in a small percentage of cases.

•Peripheral neuropathies, nerve damage,circulatory compromise and heterotopicbone formation may occur.

•Serious complications may be associatedwith any total joint replacement. Thesecomplications include, but are not limitedto: genitourinary disorders; gastrointestinaldisorders; vascular disorders, includingthrombus; bronchopulmonary disorders,including emboli, myocardial infarction or death.

•Wear of polyethylene components hasoccurred and literature reports have associated its occurrence with bone resorption, loosening and infection.

•With all implant devices, asymptomatic,localized progressive bone resorption (osteolysis) may occur around the prostheticcomponents as a consequence of foreign-body reaction to the particulate matter ofcement, metal, ultra-high molecular weightpolyethylene (UHMWPE) and/or ceramic.Particulate is generated by interactionbetween components, as well as betweencomponents and bone, primarily throughwear mechanisms of adhesion, abrasion andfatigue. Secondarily, particulate can also begenerated by third-body wear. Osteolysiscan lead to future complications, includingloosening, necessitating the removal andreplacement of prosthetic components.

•Metal sensitivity reactions have been reported following joint replacement.

•Adverse effects may necessitate reoperation,arthrodesis of the involved joint and/oramputation of the limb.

Sterilization•The packaging of all sterile products shouldbe inspected for flaws in the sterile barrierbefore opening. In the presence of such aflaw, the product must be assumed non-sterile. Special trial prostheses are availableto avoid having to open any aspect of thesterile package prior to component use.

•Care should be taken to prevent contamina-tion of the component. In the event ofcontamination, this product must be discarded.

•If the package is opened, but the product is not used, the prosthesis must not beresterilized and must be discarded orreturned to the supplier.

CAUTION: Federal law (U.S.A.) restrictsthis device to sale by or on the order of alicensed physician.

WARNING: THE GLENOID COMPONENTIS INTENDED FOR CEMENTED USEONLY IN THE U.S.A.

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Alwaysrefer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must alwaysrely on their own clinical judgment when deciding which treatments and procedures to use with patients. Products may notbe available in all markets. Product availability is subject to the regulatory or medical practices that govern individual mar-kets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

The marks bearing the symbol TM are trademarks of Stryker.The marks bearing the symbol ® are registered trademarks of Stryker.

Literature Number: LSPUE-4GC/GS 1.75m 10/04

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