S U R G I C A L T E C H N I Q U E

REVERSE SHOULDER SYSTEM

Lateralized Cup Glenosphere Threaded Head Screw

Spherical Head Screw

MetagleneEpiphysis

Diaphysis

Surgical Steps – At a Glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Preoperative Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Surgical Approach and Patient Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Superior Lateral Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Humeral Head Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Humeral Reaming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Distal Humeral Reaming (Revision Surgery) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Proximal Reamer Guide Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Proximal Humeral Reaming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Trial Humeral Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Glenoid Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

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

Metaglene Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Trial Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Glenosphere Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Humeral Implant Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Postoperative Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Contents

1

2

5. Glenoid preparation 6. Metaglene insertion

3. Diaphyseal preparation 4. Proximal reaming of the humerus

1. Superior lateral approach 2. Humeral head resection

Surgical Steps - At a Glance

The Delta CTA™ Reverse ShoulderSystem is indicated for the treatmentof glenohumeral arthritis when it isassociated with irreparable rotatorcuff damage and where conventionaltotal shoulder arthroplasty may notbe fully effective in restoring jointstability with an adequate range ofmovement. The design avoids highshear forces associated with unstableconventional or hemiarthroplasty,that can cause the implant to wearand loosen.

The Delta CTA prosthetic geometryreverses the normal relationshipbetween scapular and humeralcomponents, moving the center ofrotation medially and distally toincrease the lever arm length of thedeltoid muscle (Figures 1 and 2).

This allows the three muscles in thedeltoid group to compensate forrotator cuff deficiency, drawing thearticulating surfaces together tostabilize the joint to allow as nearnormal function as possible.

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Introduction

Figure 1 Figure 2

Anatomical center of rotation

Anatomical center of rotation

Medialized center of rotation

Introduction

The Delta CTA Reverse ShoulderSystem may be implanted using eithera transacromial or transdeltoidapproach. Preoperative planningshould take into account the quality ofthe acromion.

If the acromion is small or has beenweakened by previous acromioplasties,or in cases of severe osteoarthritiswhere there may be erosion on theinferior aspect, the transacromialapproach will not be suitable.

A lateral deltoid splitting approachprovides excellent visualization of theglenoid cavity during implantation.

Place the patient in the deck chairposition, with the affected armcompletely free and resting on asupport (Figure 4).

Make an initial assessment of thebone in the superior and inferioraspects of the glenoid, usingradiographic and CT imaging inorder to determine the suitability ofthe patient for treatment. And, ifappropriate, establish the location ofthe four metaglene screws foroptimum implant stability. Carry out preoperative planningusing AP and lateral shoulderradiographs of known magnificationand the template to confirm the sizeand alignment of the implant (Figure 3).

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Preoperative Planning Surgical Approach and Patient Positioning

Figure 3Preoperative Planning

Figure 4Patient Positioning

Preoperative Planning: Surgical Approach and Patient Positioning

The surgical approach – superiorlateral (Figure 5) or delto-pectoral –depends mainly on surgeonpreference and clinical parameters.Revision surgery, for instance, usuallydictates a delto-pectoral approach asit allows for a longer humeralincision when faced with a difficultremoval of the humeral stem.When used for classic rotator cuffrepairs, the delto-pectoral approachallows clear visualization of theglenoid and therefore facilitates theimplantation of the glenoidcomponents of the prosthesis.

Start the incision at the level of theacromioclavicular (AC) joint. Followthe anterior aspect of the acromionand finish vertically downwards for4 cm (Figure 6). Following sub-cutaneous dissection, separate theanterior and middle deltoid musclebundles opposite the lateral margin ofthe acromion, using blunt dissection.The dissection should not extendbeyond 4 cm from the externalaspect of the acromion in order topreserve the axillary nerve.When the subacromial bursa isvisible, gentle longitudinal traction inline with the limb will allow aretractor to be placed in thesubacromial space.

Release the anterior deltoidsubperiosteally from its acromialinsertion up to the AC joint.The humeral head is then visible atthe anterior edge of the acromion.Remove the subacromial bursa. Ifnecessary, exposure may be improvedby dividing the AC ligament andperforming acromioplasty. Then,externally rotate the limb anddislocate the head anterosuperiorly tofacilitate positioning of the cuttingguide. If the biceps is still present,tenodese in the bicipital groove.Retain the teres minor andinfraspinatus when present.

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Figure 5Superior Lateral Approach

Figure 6Superior Lateral Incision

Superior Lateral Approach

Superior Lateral Approach

Make an initial entry hole in theproximal humerus using an awl.Center the awl tip over and in linewith the long axis of the humerus, atthe junction of the intratuberculargroove and the articulating surface ofthe humeral head (Figure 7).

Pass the orientation pin through thehole in the resection guidecorresponding to the desiredretroversion (Figure 8a). Zero degreesof retroversion is preferred sinceexcessive retroversion will restrictjoint rotation, especially in externalrotation. Retroversion is calculatedwith reference to the axis of thehumeral epicondyles (Figure 8b).

Locate the tip of the cutting guide inthe entry hole and pass the guidedown the humeral canal until it restson the humeral head. With thehumeral resection guide rim locatedon the humeral head, align theorientation pin with thetranscondylar axis (Figures 8b and 9).

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Figure 7Awl Insertion

Figure 8aResection Guide Orientation

Humeral Head Resection

Figure 8bOrientation

OrientationPin

EpicondylarAxis

Humeral Head Resection

Starting with the smallest diameterdistal reamer attached to the T-handle, ream the distal humeralcanal in line with the long axis of thehumerus (Figure 10). The finalreamer should not exceed thetemplated proximal diameter (up tosize 4). Stop reaming when the flangeof the reamer is level with the lateralresection. Power reaming should notbe used to ream the humerus.

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Initiate humeral head resection inline with the inferior aspect of thehumeral cutting guide. Remove thehumeral cutting guide and completethe resection (Figure 9). The initialresection removes a minimal amountof bone. More bone may be removedif necessary.

Pass a forked retractor under thescapula to lower the humerus. If thisprovides clear visualization of theglenoid surface, the resection level iscorrect. If not, further resection maybe carried out.

Figure 9Head Resection

Figure 10Humeral Reaming

Humeral Reaming

Humeral Reaming

Figure 12Guide Assembly

Distal Humeral Reaming (Revision Surgery) Proximal Reamer Guide Assembly

Figure 11Reaming – Revision Surgery

Diaphyseal references Reamer references

Size 1, length 150 mm (ref. DHC115B)7.5 mm diameter (ref. ALR 075)Size 1, length 180 mm (ref. DHC118B)

Size 2, length 150 mm (ref. DHC215B)8 mm diameter (ref. ALR 008)Size 2, length 180 mm (ref. DHC218B)

Size 3, length 150 mm (ref. DHR315B)9 mm diameter (ref. ALR 009)Size 3, length 180 mm (ref. DHR318B)

Referring to the templated epiphysissize, screw the 36 mm or 42 mmproximal reaming guide to the trialdiaphyseal stem that matches thedistal reamer diameter. Mount theassembly on the humeral stemimpactor and introduce in line withthe long axis of the humerus (Figure 12).

If a long stem is to be implanted, 150 mm and 180 mm diaphysealrevision reamers should be used inconjunction with the rigid reamersthat are included within the DeltaCTA revision instrumentation (Figure 11).

In addition to the reamers in theaccompanying table, 5 mm and 6 mm diameter reamers are providedas start-up reamers.

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Distal Humeral Reaming (Revision Surgery)

Proximal Reamer Guide Assembly

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Figure 13Determining Depth

Figure 14Proximal Reaming

Pass the orientation pin through thehole in the impactor handle andcheck the previously selected versionangle. Impact the assembly into thehumeral canal until the appropriatemark (36 mm or 42 mm) on theimpactor reaches the level of theresection (Figure 13).

Check retroversion again and removethe impactor, leaving the reamingguide in place. Mount the appropriatesize proximal humeral reamer, (36.1, 36.2 or 42.2) on the T-handle.The 36 size 1 reamer removes morebone than the 36 size 2 reamer, asshown in the Delta templates. Reamthe humerus until the flange of thereamer is level with the osteotomy,and contact is made with cortical bone(Figure 14).

If necessary, insert the reaming guidemore deeply to ensure that theproximal reamer reaches the level ofosteotomy. Reaming is nowcomplete. Extract the reamer, reamerguide and trial stem from thehumerus.

Proximal Humeral Reaming

Proximal Humeral Reaming

Position an anterior glenoid neckretractor (Cat. Nos. 2810-16-000and 2810-17-000) on the axillarymargin of the scapula, under theinferior glenoid labrum, to reflectthe humerus down or backward,depending on the approach taken.Excise the labrum and perform anextensive periglenoid capsulotomy.Any peripheral osteophytes shouldbe removed to restore the naturalanatomic shape of the glenoid(Figure 16).

Glenoid Exposure

Figure 15Implant Trial Assembly

Figure 16Glenoid Exposure

Trial Humeral Implantation

Attach the trial epiphysealcomponent to the trial diaphysealstem, and mount the assemblyonto the humeral stem impactor(Figure 15). It may be necessary toremove a wedge of cortical bone toaccommodate the lateral fin on theepiphyseal component. Impact theassembly into the humeral canal,ensuring the diaphyseal fin doesnot impinge upon the lateral cortexof the humerus. Remove thehumeral stem impactor.

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Trial Humeral Implantation Glenoid Exposure

Attach the cannulated stop drill tothe power source and complete theglenoid centering hole over the guidepin (Figure 17b). Attach the glenoidreamer to the power source andintroduce the reamer pilot shaft intothe glenoid centering hole. In casesof osteoporotic bone, hand reamingshould be used. Ensure that thereamer is not in contact with bonebefore applying power since thismay damage the glenoid.

Ream the glenoid until a smoothplatform, devoid of cartilage, iscreated for the metaglene, withsufficient depth to accommodate its peripheral rim (Figure 18). Check the depth before implan-tation of the prosthesis. If sufficientperipheral depth is not achieved, theglenosphere will not fully engagewith the taper on the metaglene, andfurther reaming should be carriedout until the tray is fully seated.

Mark the major and minor axes ofthe glenoid using diathermy. Attachthe 1.5 mm guide pin to the powertool and create an entry point justposterior and inferior to theintersection of the axes (Figure 17a).The location for this entry point maybe checked using CT imaging.It should be as inferior as possible,while ensuring that sufficient space isavailable to place the entire length ofthe inferior screw in cancellous bone.

Figure 17bGlenoid Centering Hole

Figure 17aGuide Pin Placement

Glenoid Preparation

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Figure 18Glenoid Reaming

Glenoid Preparation

The metaglene is available in one sizefor both 36 mm and 42 mmglenospheres and is implantedwithout cement. Initial, primarymechanical stability is provided by the4.5 mm diameter screws. Whencorrectly positioned, the angled,threaded screw holes in the metagleneshould be aligned superiorly andinferiorly on the glenoid (Figure 19).After determining there is sufficientbone to support the metaglene andprovide screw fixation, attach thedefinitive metaglene to the holder,

with the drill guide covering theinferior threaded screw hole on theimplant. Insert the assembly into theprepared glenoid with the superiorand inferior holes aligned with thelong axis of the glenoid.Caution: It is imperative to use themetaglene holder to insert theinferior and superior screws. The80-degree angle between these twoscrews is fixed and cannot be altered.

Once the metaglene has beenmanually aligned, tap the holderfirmly so that the tray is impacted flat onto the prepared surface of the glenoid. It is important to ensurethat the metaglene is fully seated, flat on the prepared glenoid, before it is screwed into position.Then, insert a drill bush 2 or 2.5 mmin diameter, depending on the qualityof bone, into the drill guide. Selectthe corresponding drill, pass throughthe bush, and drill the inferiorfixation hole (Figure 21).

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Figure 19

Figure 20Drill Guide Orientation

Figure 21Inferior Hole Drilling

Metaglene Insertion

Superior

Anterior

Inferior

Posterior

Long Axis of the Glenoid

Anterior and PosteriorSpherical Head Screw

107˚ 34˚

Superior Threaded Head Screw

Inferior Threaded Head Screw

Metaglene Insertion

Remove the drill bush and check thedepth of the screw hole by using thedepth gauge provided (Figure 22).Threaded head screws must be usedfor the inferior and superior holes.The spherical head screws aredesigned for use only with anterior andposterior holes.

A threaded head screw of correspon-ding length to the measured depth ispassed through the drill guide andscrewed into the inferior fixationhole. The screw should be fullytightened at this stage (Figure 23).

Gently detach the metaglene holderfrom the bearing tray and turn 180degrees to prepare the superiorfixation hole in the same way as theinferior hole.

Measure its depth and screw theappropriate threaded head screw intoposition (Figure 24), again ensure itis fully tightened.

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Figure 23Screw Placement

Figure 22Depth Measurement

Figure 24Superior Hole Drilling

Remove the metaglene holder andlocate the free hand drill guide ofappropriate size, 2.0 or 2.5 mm, inthe anterior fixation hole. Bothanterior and posterior screw positionsallow angulation of ± 20 degrees. Use the drill guide to set the mostappropriate angle to ensure that eachscrew is located in reliable bone stock(Figure 25).

Preferential position is usually chosenby palpating the anterior and posterioraspects of the scapula as well asexamining the X-rays and CT scans.

Drill the anterior hole, remove thedrill guide and measure the hole depthusing the depth gauge (Figure 26).

Introduce a spherical head screw andpartially tighten (Figure 27). Followthe same procedure for the posteriorscrew. Alternately tighten both screwsuntil fully tightened (Figure 28).

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Figure 27Screw Placement

Figure 28Final Screw Tightening

Figure 26Depth Measurement

Figure 25Anterior Hole Drilling

Attach the appropriate trialglenosphere (36 mm or 42 mm) tothe metaglene. Insert thecorresponding lateralized humeralcup trial into the humeral trialassembly. Reduce the shoulder andassess for a full range of movement.If soft tissue tension is correct, theglenoid bearing will not impinge onthe inferior rim of the resectedhumeral head (Figure 29). When thearm is pulled down and outward,approximately 5 mm of humeral-glenoid component separation maybe expected.

The joint should remain stable whenthe arm is abducted, with noindication of superior subluxation(Figure 30). Additional joint stabilitymay be achieved by introducing aretentive, more constrained cup. Iffurther soft tissue tension is required,a +9 mm humeral spacer may beattached to the trial epiphysealcomponent, using the hexagonalhead screwdriver.

Trial Reduction

A retentive cup should only be usedin revision cases or to correctextreme instability. If the humeralcut is adequate, a lateralized cup willbe sufficient in the majority of cases.

Figure 29 Figure 30

No Impingement

on Inferior Rim

No Superior Subluxation

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Trial Reduction

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Insert a 1.5 mm guide pin throughthe central hole of the metaglene(Figures 31 and 32). Engage the3.5 mm cannulated screwdriver in thedefinitive glenosphere and guide overthe 1.5 mm guide pin.

After two or three turns, disengagethe cannulated screwdriver and checkthe glenoid bearing to ensure properalignment. Then re-engage thecannulated screwdriver and tightenthe captive screw until the glenoidbearing closes on the taper of thebearing tray. Ensure that the glenoidbearing is fully locked onto thebearing tray (Figure 33).

Figure 31Inserting Guide Pin

Figure 32Guiding Glenosphere

Figure 33Engaging Glenosphere

Glenosphere Placement

Glenosphere Placement

Figure 34Attaching Epiphyseal Component

Figure 35Attaching Diaphyseal Component

If it was determined during trialreduction that a humeral spacer isneeded, attach the humeral spacer tothe epiphyseal component using thehex driver and wrench.

Introduce a cement restrictor, such asBIOSTOP® G or a bone plug, intothe distal humeral canal to restrictthe passage of cement. Introducecement, such as SmartSet® HV or

DePuy 1 (high viscosity bonecements) or Endurance® (mediumviscosity bone cement), into thehumeral canal and, when the cementis at its appropriate viscosity, intro-duce the implant assembly in linewith the long axis of the humerus andin the chosen version angle. Maintainpressure on the introducer until thecement is fully polymerized.

Humeral Implant Insertion

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Humeral Implant Insertion

Extract the trial humeral assemblyfrom the humerus. Attach thecorresponding definitive humeralepiphyseal component to theimpactor (Figure 34). Screw thedefinitive diaphyseal component tothe epiphyseal component. Lock thetwo components using the wrenchand driver (Figure 35).

Using the cup impactor, impact thedefinitive humeral cup. Ensure it isfully seated and secure into the snapfit (Figure 36). Reduce the joint andmake a final assessment of jointstability and range of motion.

Figure 36Impacting Humeral Cup

Humeral Implant Insertion

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Once the joint space is irrigated andcleared of debris, firmly suture theanterior deltoid at the fibrous acromialperimeter or use transosseous stitches. A drain may be left in place. Layeredclosure of the soft tissues normally leads to an adequate range of motion,without instability.

Appropriate postoperativephysiotherapy is an important factor inthe outcome of this procedure, sincestability and mobility now depend onthe deltoid alone. The physiotherapyprogram, which should be planned tosuit the individual patient, consists oftwo phases: early (6 weeks) and late. Two days after the operation thepatient can be mobile. This early phaseis dedicated to gentle and gradualrecovery of the passive range ofshoulder motion: abduction of thescapula, anterior elevation and medialand lateral rotation. An abductioncushion may be used to relieve pressureon the deltoid.

Physiotherapy is mainly performedwith the patient supine, passive andwith both hands holding a bar that ismanipulated by the contralateral hand,as described by Neer.

Postoperative Management

The patient is encouraged to use theaffected arm to eat and write butshould not raise the arm. Inconjunction with these exercises forscapulohumeral recovery, it isimportant to strengthen muscleconnection with the scapula in orderto facilitate muscle and implantfunction. Passive exercise in theswimming pool is recommended assoon as scars begin to form.After the sixth or seventh week, activestrengthening movements may begradually added to the program. Theseexercises, which closely follow everydayactivities, are performed in a sitting orstanding position, using conventionalmethods, with isometric exercises andresistance movements becomingincreasingly important.

A series of exercises for rhythmicstabilization of the upper arm as wellas eccentric working on lowering thearms complete the strengthening of themuscles. Physiotherapy should beperformed over a period of at least six months.

Closure

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ImplantCat. No. DescriptionEHC361B Cemented Humeral Epiphysis, 36.1 mmEHC362B Cemented Humeral Epiphysis, 36.2 mmEHC422B Cemented Humeral Epiphysis, 42.2 mm

DHC010B Cemented Humeral Diaphysis, Size 0DHC110B Cemented Humeral Diaphysis, Size 1DHC210B Cemented Humeral Diaphysis, Size 2DHC310B Cemented Humeral Diaphysis, Size 3DHC410B Cemented Humeral Diaphysis, Size 4

4CHS036R Retentive Humeral Cup, 36 mm4CHL636 Lateralized Humeral Cup, 36 mm + 6 4CHL636R Lateralized Retention Humeral Cup, 36 mm + 6 4CHS042R Retentive Humeral Cup, 42 mm4CHL642 Lateralized Humeral Cup, 42 mm + 6 4CHL642R Lateralized Retention Humeral Cup, 42 mm + 6

RTH236 Humeral Spacer, 36 mm + 9RTH242 Humeral Spacer, 42 mm + 9

MGC002H Standard Metaglene

GSC236 Glenosphere 36 mmGSC242 Glenosphere 42 mm

VFM4524 Metaglene Screws, Dia. 4.5 x 24 mm (Threaded Head)VFM4530 Metaglene Screws, Dia. 4.5 x 30 mm (Threaded Head)VFM4536 Metaglene Screws, Dia. 4.5 x 36 mm (Threaded Head)VFM4542 Metaglene Screws, Dia. 4.5 x 42 mm (Threaded Head)VFM4548 Metaglene Screws, Dia. 4.5 x 48 mm (Threaded Head)VSM4518 Metaglene Screws, Dia. 4.5 x 18 mm (Spherical Head)VSM4524 Metaglene Screws, Dia. 4.5 x 24 mm (Spherical Head)VSM4530 Metaglene Screws, Dia. 4.5 x 30 mm (Spherical Head)VSM4536 Metaglene Screws, Dia. 4.5 x 36 mm (Spherical Head)VSM4542 Metaglene Screws, Dia. 4.5 x 42 mm (Spherical Head)

Ordering Information

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Cat. No. DescriptionGSH002 Humeral Resection Guide

ARR001 Orientation Pin

FPH361 Proximal Humeral Reamer, 36.1FPH362 Proximal Humeral Reamer, 36.2FPH422 Proximal Humeral Reamer, 42.2

FDH036N Distal Humeral Reamer, Size 0, Dia. 36FDH136 Distal Humeral Reamer, Size 1, Dia. 36FDH236 Distal Humeral Reamer, Size 2, Dia. 36FDH336 Distal Humeral Reamer, Size 3, Dia. 36FDH436 Distal Humeral Reamer, Size 4, Dia. 36FDH142 Distal Humeral Reamer, Size 1, Dia. 42FDH242 Distal Humeral Reamer, Size 2, Dia. 42FDH342 Distal Humeral Reamer, Size 3, Dia. 42FDH442 Distal Humeral Reamer, Size 4, Dia. 42

ITH003 Humeral Stem Impactor

EHF001 Forked Retractor

EHF002 U-forked Retractor

GFP136 Proximal Reamer Guide, Dia. 36GFP142 Proximal Reamer Guide, Dia. 42

IGF004 Reamer Guide Impactor/Extractor

CLE014 Diaphyseal Stem Locking Wrench

DHF010N Humeral Diaphysis Trial, Size 0DHF110 Humeral Diaphysis Trial, Size 1DHF210 Humeral Diaphysis Trial, Size 2DHF310 Humeral Diaphysis Trial, Size 3DHF410 Humeral Diaphysis Trial, Size 4

EHF361 Humeral Epiphysis Trial, 36.1EHF362 Humeral Epiphysis Trial, 36.2EHF422 Humeral Epiphysis Trial, 42.2REH236 Humeral Spacer Trial, Dia. 36REH242 Humeral Spacer Trial, Dia. 42

A5265 Standard Humeral Retention Cup Trial, Dia. 36A5264 Lateralized Humeral Cup Trial, Dia. 36A5263 Lateralized Humeral Retention Cup Trial, Dia. 36A5262 Standard Humeral Retention Cup Trial, Dia. 42A5261 Lateralized Humeral Cup Trial, Dia. 42A5260 Lateralized Humeral Retention Cup Trial, Dia. 42

Humeral Preparation Instruments

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Cat. No. DescriptionA5266 Guide Pin

A5267 Cannulated Stop Drill

A5075 Glenoid Surfacing Rasp, Dia. 36 A5076 Glenoid Surfacing Rasp, Dia. 42

PAM001 T-handle

A5271 Drill Bush, Dia. 2.0A5272 Drill Bush, Dia. 2.5

GPM020 Drill Guide, Dia. 2.0GPM025 Drill Guide, Dia. 2.5

A5326 S/I Drill Bit, Dia. 2.0 (170 mm Length)A5327 S/I Drill Bit, Dia. 2.5 (170 mm Length)

MPG020 A/P Drill Bit, Dia. 2.0 (100 mm Length)MPG025 A/P Drill Bit, Dia. 2.5 (100 mm Length)

A5273 Glenosphere Trial, Dia. 36A5274 Glenosphere Trial, Dia. 42

9E03011 3.5 mm Hex. Head Screwdriver, CannulatedA5307 Screw Depth Gauge

PRT001 Standard Impactor Holder

EPT001 Humeral Head ImpactorEPC032 Humeral Cup Impactor

A5074 1.5 mm Guide Wire

A5268 Metaglene Holder

TraysCat. No. DescriptionA5807 Glenoid Tray BaseA5806 Glenoid Tray InsertA5812 Glenoid Tray LidA5815 Glenoid Tray Screw Rack

A5809 Humeral Tray 1 BaseA5808 Humeral Tray 1 InsertA5813 Humeral Tray 1 Lid

A5811 Humeral Tray 2 BaseA5810 Humeral Tray 2 InsertA5814 Humeral Tray 2 Lid

ImplantCat. No. DescriptionDHC115B Revision Cemented Humeral Diaphysis (150 mm), Size 1DHC215B Revision Cemented Humeral Diaphysis (150 mm), Size 2DHC315B Revision Cemented Humeral Diaphysis (150 mm), Size 3DHC118B Revision Cemented Humeral Diaphysis (180 mm), Size 1DHC218B Revision Cemented Humeral Diaphysis (180 mm), Size 2DHC318B Revision Cemented Humeral Diaphysis (180 mm), Size 3

Glenoid Preparation Instruments

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InstrumentsCat. No. DescriptionETH001 Standard Humeral Prosthesis ExtractorMDE001 Extraction RodMAI001 Slap HammerITH003 Delta Stem ExtractorTEP035 3.5 mm Hex. Head ScrewdriverTEP025 2.5 mm Hex. Head ScrewdriverALR005 Diaphyseal Reamer, Dia. 5 mmALR006 Diaphyseal Reamer, Dia. 6 mmALR075 Diaphyseal Reamer, Dia. 7.5 mmALR008 Diaphyseal Reamer, Dia. 8 mmALR009 Diaphyseal Reamer, Dia. 9 mm

DHF115 150 mm Long Humeral Diaphysis Trial, Size 1DHF215 150 mm Long Humeral Diaphysis Trial, Size 2DHF315 150 mm Long Humeral Diaphysis Trial, Size 3DHF118 180 mm Long Humeral Diaphysis Trial, Size 1DHF218 180 mm Long Humeral Diaphysis Trial, Size 2DHF318 180 mm Long Humeral Diaphysis Trial, Size 3

A5288 Metaglene Extractor

TraysCat. No. DescriptionA5280 Tray BaseA5281 Tray InsertA5279 LidA5287 Label for Revision Tray Sterilization ContainerA5194 Sterilization Container 550 x 265 x 167 mmA5066 Bottom Plate 550 x 265 x 167 mmA5054 Lid for Container 550 x 265 mm

Delta Revision

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For more information about DePuy products, visit our web site at www.jnjgateway.com.

Further Reading:

1. Baulot E, Garron E, Grammont P. La prothèse de Grammont dans lescas d’ostéonécrose de la tête humérale. Acta Orthopaedica Belgica, Vol 65 Suppl. 1, 1999.

2. Bouttens D, Nérot C. G.E.E.D. La prothèse Delta dans l’omarthroseexcentrée. Résultats à moyen et long terme (1991 -1994).Communication présentée au Congrès de la prothèse d’épaule, Paris,January, 2000.

3. Bradley Th, Boulahia A, Walch G, Baratta R. Early results of a reversedesign prosthesis in the treatment of arthritis of the shoulder inelderly patients with a large rotator cuff tear. Presented at AAOS,Dallas, February, 2002.

4. Cazeneuve JF, Saltanove I. Reverse total shoulder arthroplasty(Grammont’s arthroplasty) for acute complex fractures of proximalhumerus. Five years experience. Presented at SECEC, June, 1998.

5. De Wilde L, Mombert M, Van Petegem P, Verdonk R. Revision ofthe shoulder replacement with a reversed shoulder prosthesis (DeltaIII): report of five cases. Acta Orthopaedica Belgica, Vol 67, 2001.

6. Gerber A, Roache P, Gerber C. The Delta III reversed prosthesis:weapon of the devil or an acceptable salvage procedure. Presented atthe 8th ICSS, Cape Town, April, 2001.

7. Grammont P, Trouilloud P, Laffay JP, Deries X. Etude et réalisationd’une nouvelle prothèse d’épaule. Rhumatologie, 39, 407-418, 1987.

8. Grammont P. Shoulder prosthesis for rotator cuff rupture. Ed. Theshoulder, Groningen, 1991.

9. Grammont P, Baulot E. Delta shoulder prosthesis for rotator cuffrupture. Orthopaedics, Vol.16, 1, 65-68, 1993.

10. Grammont P, Baulot E, Chabernaud D. Résultats de la prothèseinversée de Grammont pour des omarthroses associées à de grandesdestructions de la coiffe. Acta Orthopaedica Belgica, Vol. 61, Suppl.1,112-119, 1995.

11. Jacobs R, Debeer, De Smet L. Treatment of rotator cuff arthroplastywith a Delta shoulder prosthesis. Acta Orthopaedica Belgica, Vol 67,2001.

12. Kralinger F, Golser K, Smekal V. First experiences with the Delta IIIinversprosthesis. Presented at the 8th ICSS, Cape Town, April, 2001.

13. Lee D. Bipolar shoulder arthroplasty. Clin Orthop. 304, 1994.14. Sirveaux F, Favard L, Oudet D, Huguet D, Lautman S. Grammont

inverted total shoulder arthroplasty in the treatment of glenohumeralosteoarthritis with massive and non repairable cuff rupture. Presentedat the Congress 2000 Shoulder Prostheses. Two to ten year follow-up.Nice, September, 2001.

15. Slimani S, Coudane H, Marçon D, Lesur E. Evaluation des repriseschirurgicales des prothèses totales d’épaule: étude longitudinaleprospective. Communication présentée à la 76 ème réunion annuellede la SOFCOT. November, 2001.

16. Valenti P, Bouttens D, Nérot C, GED : Delta III reversed prosthesisfor osteoarthritis with massive rotator cuff tear: long term results (> 5years). Presented at the Congress 2000 Shoulder Prostheses. Two toten year follow-up. Nice, September, 2001.

17. Valenti P, El-Abiad R. Repair of rotator cuff tears in patients olderthan 65 years: report of 46 cases. Presented at the 8th ICSS, CapeTown, April, 2001.

18. Valenti P, Sbihi A. Inverted Delta III prothesis in non reconstructablerotator cuff lésions: report of 25 cases. Presented at the 8th ICSS,Cape Town, April, 2001.

19. Valenti P, Sauzières P, Bouttens D, Nérot C. Résultats de 19 prothèsesinversées " Grammont " implantées après échec d’hémiarthroplastiesou d’arthroplastie totale de l’épaule. Communication présentée à la76 ème réunion annuelle de la SOFCOT. November, 2001.

2M0204 Printed in USA.0612-26-500 ©2004 DePuy Orthopaedics, Inc. All rights reserved.

IMPORTANT This essential product information does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessaryinformation.

INDICATIONS Delta shoulder replacement is indicated for use in grossly rotator cuff deficient joints with severe arthropathy, or for use when a previous joint replacement hasfailed with a grossly rotator cuff deficient joint. A functional Deltoid muscle is needed for use of this device. Also, the patient’s joint must be anatomically andstructurally suited to receive the device.

The metaglene component is for cementless use only. All other components are intended for cemented use only.

CONTRAINDICATIONSThe following are contraindications for shoulder arthroplasty: 1. Active local or systemic infection; 2. Poor bone quality and/or inadequate bone stock to appropriately support the prosthesis; 3. Severe deformity;4. Muscle, nerve or vascular disease;5. Obesity, drug abuse, over activity or mental incapacity.

WARNINGS AND PRECAUTIONSThe following conditions tend to adversely affect the fixation of the shoulder replacement implants:1. Marked osteoporosis or poor bone stock;2. Metabolic disorders or systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant

(e.g., diabetes mellitus, steroid therapies, immunosuppressive therapies, etc.);3. History of general or local infections;4. Severe deformities leading to impaired fixation or improper positioning of the implant;5. Tumors of the supporting bone structures;6. Allergic reactions to implant materials (e.g. bone cement, metal, polyethylene);7. Tissue reactions to implant corrosion or implant wear debris;8. Disabilities of other joints.

ADVERSE EVENTSThe following are the most frequent adverse events encountered after total or hemi-shoulder arthroplasty: 1. Change in position of the prosthesis, often related to factors listed in WARNINGS AND PRECAUTIONS.2. Early or late infection;3. Early or late loosening of the prosthetic component(s), often related to factors listed in WARNING AND PRECAUTIONS;4. Temporary inferior subluxation. Condition generally disappears as muscle tone is regained;5. Cardiovascular disorders including venous thrombosis, pulmonary embolism and myocardial infarction;6. Hematoma and/or delayed wound healing;7. Pneumonia and/or atelectasis;8. Subluxation or dislocation of the replaced joint.