Constrained Acetabular Insert

Orthopaedics

Surgical Protocol

Trident®

Trident®

Constrained Acetabular InsertSurgical Protocol

Table of Contents

Introduction 1

Stryker Trident® Constrained Acetabular Insert 1

Cementless OptionsPrimary Surgery 3Revision Surgery 3Revising the Metal Shell 3Retaining the Metal Shell 3

Trial Evaluation 3

Component Selection 3

Implantation 3

Femoral Bearing Head / Insert Assembly 5

Constrained Insert Removal 5

Cementable Options 6

Trident® Constrained Acetabular Insert Trials 7

Postoperative Care, Indications, Contraindications

and Warnings 10

1

Acetabular Shell (Metal)

Outer Bearing UHMWPEThickness

Insert (UHMWPE)

Bipolar Outer FemoralHead (CoCr)

Bipolar Retaining RingUHMWPE

Locking Ring(Titanium Alloy)

Bipolar UHMWPEInsert

Trident® ConstrainedAcetabular Inserts

Trident® 0° Constrained Acetabular Insert

Trident® 10° Constrained Acetabular Insert

Trident® 0° All-Poly Constrained Acetabular Insert

Introduction

The Trident® Constrained AcetabularInsert is indicated for use in primary andrevision total hip patients who exhibit ahigh risk of hip dislocation. It should beused when more conservative methodsof soft tissue management, such aslengthening the femoral neck or lateral -izing the joint’s center of rotation, areinsufficient for restoring joint stability.

The Trident® Constrained AcetabularInsert offers less range of motion thanstandard total hip replacement com -ponents but can be a better solution whenthe likelihood of dislocation is high.

Trident® ConstrainedAcetabular Insert

The Trident® Constrained AcetabularInsert is designed specifically for theStryker UHR® bipolar head. The bipolarhead is preassembled in the insert andsecurely retained by a titanium alloyretaining ring. The Trident® 0° and 10°Constrained Acetabular Inserts can onlybe used in a Trident® Acetabular Shell.

The Trident® 0° All-Poly ConstrainedInsert can be cemented into an existingshell or cage device, or directly into theacetabulum.

Articulation occurs at both the femoralhead-to-bipolar interface and at thebipolar-to-insert interface.

A unique, split-ring locking mechanismfacilitates ease of femoral head assembly,yet provides the potential for enhancedprotection against componentdisassembly.

A head removal key allows for easy,non-destructive component disassembly.

A dynamic valgus alignment creates a constant neutral alignment of thebipolar within the insert during weightbearing to provide increased headcoverage. This prevents inner bearingarticulation from occurring on thelocking mechanism, thus sparing themechanism from extreme loading.

2

*The alphabetical letter at the end of a Trident® catalog number identifies compatibility among all Trident® acetabular components.**NOTE: Special Key for 690-00-22D, 690-00-22E and 690-10-22E, 690-10-22F, 69-2244,69-2246, 69-2248 only.***Values calculated using Accolade® TMZF Size 3 stems.

Table 2: Trident® 10° Constrained Inserts

Trident® Trident® Bipolar Bipolar Outer Bearing Total Outer Bearing Insert

Alpha Constrained Femoral Head OD UHMWPE Range of OD Spherical Head Removal Trial

Code* Insert Head Size (mm) Thickness Motion*** Diameter Key Catalog CatalogCatalog No. (mm) (mm) (mm) Number No.

E 690-10-22E 22 36 7.9 82° 44.4 HI-UHRK-3638** 2230-22EF 690-10-22F 22 36 9.9 82° 48.4 HI-UHRK-3638** 2230-22FG 690-10-28G 28 42 8.4 90° 51.5 HI-UHRK-28 2230-28GH 690-10-28H 28 42 10.2 90° 55.0 HI-UHRK-28 2230-28HI 690-10-28I 28 42 11.6 90° 58.0 HI-UHRK-28 2230-28IJ 690-10-28J 28 42 13.7 90° 62.0 HI-UHRK-28 2230-28J

Table 3: Trident® 0° All-Poly Constrained InsertsTrident® Bipolar Bipolar Outer Bearing Total Outer Bearing Head RemovalConstrained Femoral Head OD UHMWPE Range of OD Spherical Key Catalog Insert Trial

Insert Catalog Head Size (mm) Thickness Motion*** Diameter (mm) Number Catalog No.No. (mm) (mm)

69-2244 22 36 7.3 82° 44.0 HI-UHRK-3638** 1090-224469-2246 22 36 8.3 82° 46.0 HI-UHRK-3638** 1090-224669-2248 22 36 9.3 82° 48.0 HI-UHRK-3638** 1090-224869-2850 28 42 7.3 90° 50.0 HI-UHRK-28 1090-285069-2852 28 42 8.3 90° 52.0 HI-UHRK-28 1090-285269-2854 28 42 9.3 90° 54.0 HI-UHRK-28 1090-285469-3256 32 46 8.3 94° 56.0 HI-UHRK-32 1090-325669-3258 32 46 9.3 94° 58.0 HI-UHRK-32 1090-325869-3260 32 46 10.3 94° 60.0 HI-UHRK-32 1090-3260

Table 1: Trident® 0° Constrained Inserts

Trident® Trident® Bipolar Bipolar Outer Total Outer Head RemovalAlpha Constrained Femoral Head OD UHMWPE Range of OD Spherical Key Catalog Insert

Code* Insert Catalog Head Size (mm) Thickness Motion*** Diameter Number Catalog No.Number (mm) (mm) (mm)

D 690-00-22D 22 36 5.6 82° 40.4 HI-UHRK-3638** 2270-22DE 690-00-22E 22 36 7.5 82° 44.4 HI-UHRK-3638** 2270-22EF 690-00-28F 28 42 6.5 90° 48.5 HI-UHRK-28 2270-28FG 690-00-28G 28 42 8.1 90° 51.5 HI-UHRK-28 2270-28GH 690-00-32H 32 46 7.8 94° 55.0 HI-UHRK-32 2270-32HI 690-00-32I 32 46 9.3 94° 58.0 HI-UHRK-32 2270-32IJ 690-00-32J 32 46 11.3 94° 62.0 HI-UHRK-32 2270-32J

3

Cementless Options

Primary Surgery:When used in a primary surgery, theStryker femoral and Trident® metal shellcomponents should be implanted inaccordance with the applicable SurgicalProtocols. However, if an uncementedmetal shell is being implanted with theTrident® Constrained Acetabular Insert,supplemental fixation, with a minimumof two (2) bone screws, is recommended.

Revision Surgery:When the Trident® Constrained AcetabularInsert is chosen for use in the revision of a Trident® Acetabular Component, the existing Trident® insert should be removed in accordance with theappropriate Stryker Surgical Protocol.

Care should be taken not to mar theinterior of the existing metal shell whenremoving the insert. The stability of the metal shell and the locking barbsmust be assessed for any damage. Also,remove any tissue that may get wedgedbetween the insert and shell lip.

Revising the Metal Shell:If the shell requires replacement due to instability, bone loss, damage to the locking ring groove, or any othercondition, the metal shell may bereplaced with a Stryker Trident® shell in accordance with the appropriateSurgical Protocol. If an uncementedmetal shell is being implanted with theTrident® Constrained Acetabular Insert,supplemental fixation, with a minimumof two (2) bone screws, is recommended.

Retaining the Metal Shell:Once the integrity of the existing metal shell is established, remove anymembranes from the screw holes andinside the shell. Also remove any tissuethat may impinge the polyethylene linerengagement at the periphery of themetal shell.

Trial EvaluationThe appropriate size Trident® ConstrainedTrial Insert is selected to evaluate jointmechanics (Figure 1). Refer to the trialtable on page 6 for the appropriate sizetrial insert. The Trident® ConstrainedTrial Inserts contain a screw mechanismto secure the trial to the acetabular shell.The trial insert is inserted into theTrident® Acetabular Shell and the screwmechanism must be tightened by usingthe Stryker Torx Screw Drivers. Once

the trial insert is fully seated, the trialreduction can be performed. Once thetrial reduction is performed, remove the trial insert.

Component SelectionSelect the appropriate sized Trident®Constrained Acetabular Insert bycorrelating the insert letter designation(alpha code) with that of the shell (See Tables 1 & 2 on page 2).

ImplantationFor proper seating and locking of theconstrained insert, the insert must beboth rotationally and axially aligned to the acetabular shell prior to finalimpaction. While holding the insert inyour fingers, rotationally align the insertlocking grooves to the barbs of the shellmaking sure the location of the 10° lipmatches that of the trial insert.

Once the insert is rotationally aligned,press the insert into the shell whilekeeping the axis of the insert parallel to the axis of the shell (Figure 2).

Push the insert into the shell until theinsert will not go any further. Care mustbe taken not to rock, tilt, or misalignthe insert prior to final impaction, asthis may damage the polyethylenelocking bead thus preventing properseating and locking.

Locking of the Trident® ConstrainedAcetabular Insert into the appropriatelysized Trident® metal shell is the same asstandard Trident® Acetabular PolyethyleneInserts. The constrained insert, however,cannot be impacted into the shell withthe Stryker Acetabular Cup InsertImpactor (2101-0130).

Locking Insert into ShellMethod OneSelect the ConstrainedLiner Inserter/ImpactorTip (2199-20XX or 2199-20XX Rev. C or greater)that cor responds to thefemoral head size (Figure 3).If using the 2199-20XXImpactor Tip – Threadthe tip onto the Trident®Cup Positioner / Impactorhandle (2101-0200,Figure 4A). If using the2199-20XX Rev. C orgreater Impactor Tip –Thread the metal adapteronto the tip. Load the tipinto the Insert Positioner /Impactor Handle (2111-0000B, Figure 4B). Insertthe tip into the bipolar(Figure 5). Impact theinsert to its final seatingwith the rim of theImpactor Tip flush withthe face of the insert.Check for proper seatingby assuring that theperiphery of the insert isin contact with the shell,circumferentially.

Figure 2 (10° insert shown)

Figure 3 Figure 5

Figure 1

Figure 4A

Figure 4B

4

Method TwoUse the Cutting Edge Femoral HeadImpactor (1104-1000) to strike againstthe spherical surface of the inner bipolarmetal shell. Alternatively, the CommandFemoral Head Impactor (6266-0-140)may be used. Impact the insert to itsfinal seating with the force andinstrument perpendicular to the shellface. Check for proper seating by assuring that the periphery of theinsert is in contact with the shell,circumferentially.

Method ThreeSelect a Threaded Trial Head (1205-0022 / 1205-0028 / 1205-0032) with thesame outer diameter as the innerdiameter of the chosen constrainedinsert. Also, select an appropriatelysized Head Removal Key (HI-UHRK-3638 / HI-UHRK-28 / HI-UHRK-32).

WARNING: Ensure the Head RemovalKey is available to remove theThreaded Trial Head before proceeding.

Assemble the Howmedica OsteonicsThreaded Trial Head onto theHowmedica Osteonics ThreadedImpactor/Extractor Handle (2101-0004).

Once assembled, insert the ThreadedTrial Head into the bipolar componentof the constrained insert. Impact theinsert to its final seating with the forceand instrument perpendicular to the

shell face. Check for proper seating byassuring that the periphery of the insertis in contact with the shell,circumferentially. Once the insert isseated, remove the Threaded Trial Head /Impactor / Extractor Handle assemblyfrom the constrained bearing insertwith the selected Head Removal Key.

Use of the Head Removal Key

Insert the Head Removal Key into theinner bearing area between the bipolarcomponent and the Threaded TrialHead of the Impactor / Extractor andpush upward toward the UHR® headcenter. This spreads the locking ringwithin the UHR® component. With agentle pulling action, remove theImpactor / Extractor Handle assemblyand the key from the constrained insertat the same time.

5

allow the drill access to the medial wallof the insert. Using a 3.3mm drill bit,create a hole slightly off-center of themedial wall of the insert. Caution shouldbe taken to avoid drilling through thedome hole of the metal shell. The deep -ening of this hole should be stoppedbefore contact is made with the innersurface of the metal shell.

The appropriately-sized bone screw is started into the drill hole (a 35mmscrew length or longer is recommended).Advance the screw until the tip contactsthe inner surface of the metal shell.Continued advancement of the screwlevers the cup insert from its seatedposition. Once the cup insert has beenlifted from its fully-seated position bythe bone screw, additional distractiveforce may be applied with an elevator or osteotome.

If access to the medial wall of the insertis unattainable, the titanium alloyretaining ring on the outer rim of theacetabular insert may be removed usingan osteotome and/or forceps. Insertremoval may proceed as indicated above,only in the area of the outer rim of the insert.

The cup insert may also be removed byutilizing an osteotome, elevator and/orforceps at the cup insert/metal shelljunction, to pry the insert from itslocked position within the cup shell.

Table 4:Femoral Head Compatibility with Stryker Trident® Constrained Insert

Femoral Head Component Catalog Number Series CoCr Morse Taper 1001-XXXXCoCr C-Taper 6001-XXXXCoCr/LFIT™ Morse Taper 01-XXXX and S-1399-HHXXCoCr/LFIT™ C-Taper 06-XXXX and S-1400-HHXXAlumina C-Taper 17-XXXXEDelta Ceramic C-Taper 18-XXXXModified V40™ CoCr 6260-4-XXX and 6260-5-XXXCoCr/LFIT V40™ 6260-9-XXXAlumina V40™ 6260-7-XXX and 6565-0-XXXDelta Ceramic V40™ 6570-0-XXXPCA® CoCr +15mm 2284-0-XXXModified PCA® CoCr 6280-0-XXX

Femoral Bearing Head/InsertAssemblyAfter assembly of the constrained insertinto the metal shell, the head of theimplanted femoral stem is positioned on the opening of the constrainedinsert’s bipolar component. If utilizing a femoral stem with a modular femoralhead, the modular femoral head must be fully seated onto the femoral stemtrunnion prior to assembly with theTrident® Constrained Acetabular Insert(See Table 2 for head compatibility).The bipolar component’s opening must be fully visible before introducingthe femoral bearing head into thecomponent.

Reduce the stem in the standard fashion by elevating the patient’s leg and applying a slight downward forceuntil the head snaps into the bipolarcomponent. The bipolar component has a positive locking mechanism whichenables the bipolar and femoral head tobe assembled with less than five poundsof force. The locking mechanismconsists of a split polyethylene ringwhich is captured within the bipolar’spolyethylene insert. As the femoral headis inserted into the bipolar, the assemblyload forces the expansion of the splitring within the bipolar. Upon clearingthe maximum diameter of the head, the

ring contracts to its normal diameter,resulting in the entrapment of the headwithin the bipolar.

Once the joint is reduced, the femoralhead is retained within the constrainedinsert and can be removed only throughuse of a Stryker UHR® Head RemovalKey.

Use of the Head Removal KeyInsert the Head Removal Key into theinner bearing area between the bipolarcomponent and the Threaded Trial Headof the Impactor/Extractor and pushupward toward the UHR® head center.This spreads the locking ring within theUHR® component. With a gentle pullingaction, remove the Impactor/ ExtractorHandle assembly and the key from theconstrained insert at the same time.

Constrained Insert RemovalRemoval of the constrained acetabularcup insert, if necessary, may beaccomplished using a 3.3mm drill bit and a self-tapping bone screw with3.4mm or higher major thread diameterand a round bullet tip. Rotate the bipolarcomponent within the cup insert to

Figure 6 Head Removal Key

6

Cementable Options

Option 1: Cementing into an ImplantedShell or Cage:Following the fixation of a shell or cagedevice, a Trident® All-Poly ConstrainedInsert may be cemented into the device.

TrialingTo assess head center placement, a trialreduction may be performed by usingthe appropriate Trident® All-PolyConstrained Trial Insert and head trialto assess joint mechanics and appropri-ate head center placement. Refer to thetrial table on page 6 for the appropriatesize trial insert. The Trident® All-PolyConstrained Trial Inserts contain ascrew mechanism to secure the trial to a shell or cage with compatible domehole threads. The screw mechanismmust be tightened using the StrykerTorx Screwdrivers.

NOTE: The insert trials are the samesize as the actual implant, and do nottake into account a cement mantle.

Cementing and Inserting ImplantOnce trial reduction is complete, theinsert can now be cemented in place(see Table 3 on page 2).

Method One

If using the 2199-20XX ImpactorTip – Thread the Constrained LinerInserter/ Impactor Tip onto the Trident®Cup Impactor handle. Place the antever-sion rod in the correct position.

If using the 2199-20XX Rev. C orgreater Impactor Tip – Thread themetal adapter onto the tip. Load the tipinto the Insert Positioner / ImpactorHandle.

Mount the selected Trident® All-PolyConstrained Insert on the inserter tip(Figure 5 on page 3). Mix one pack ofSimplex bone cement according to themanufacturer’s specifications and lavagethe inside of the cup shell. Dry thor-oughly prior to the introduction of thebone cement. The cement is mixed andis inserted into the acetabular shell inbolus form. Once it has achieved a doughystate, the insert, mounted on the insertertip, is then pressed gently into the cupand driven deeply into the bed of cement.The angle guide allows assessment ofproper cup position, which is typically40 to 45 degrees of abduction or lateralopening and 10 to 20 degrees of antev-ersion.

NOTE: When determining the properangulation of the insert, it is important tocritically evaluate the anatomic landmarksand patient anatomy for optimumplacement.

It is essential that the insert be com-pressed into the cup and the introducerheld as still as possible until cement hashardened. After the cement is cured, the insert introducer is then carefullyremoved from the insert. Take specialmeasures to remove all excess bonecement from the edges of the cup byutilizing curettes and osteotomes.

Method Two

Select a Threaded Trial Head (1205-0022/ 1205-0028 / 1205-0032) with the sameouter diameter as the inner diameter ofthe chosen constrained insert. Also,select an appropriately sized HeadRemoval Key (HI-UHRK-3638 / HI-UHRK-28 / HI-UHRK-32).

WARNING: Ensure the Head RemovalKey is available to remove theThreaded Trial Head before proceeding.

Assemble the Howmedica OsteonicsThreaded Trial Head onto theHowmedica Osteonics ThreadedImpactor/Extractor Handle (2101-0004).

Once assembled, insert the ThreadedTrial Head into the bipolar componentof the constrained insert. Mix one packof Simplex™ bone cement according tothe manufacturer’s specifications andlavage the inside of the cup shell. Drythoroughly prior to introduction of thebone cement. The cement is mixed andis inserted into the acetabular shell inbolus form. Once it has achieved adoughy state, the insert, mounted onthe introducer (Impactor / ExtractorHandle Assembly), is then pressed gen-tly into the cup and driven deeply intothe bed of cement.

NOTE: When determining the properangulation of the insert, it is importantto critically evaluate the anatomic land-marks and patient anatomy for opti-mum placement.

It is essential that the insert be com-pressed into the cup and the introducer(Impactor / Extractor Handle Assembly)held as still as possible until cement hashardened. After the cement is cured, theinsert introducer (Impactor / ExtractorHandle Assembly) is then carefullyremoved from the insert with the selectedHead Removal Key. Take special measuresto remove all excess bone cement fromthe edges of the cup by utilizing curettesand osteotomes.

Use of the Head Removal Key

Insert the Head Removal Key into theinner bearing area between the bipolarcomponent and the Threaded TrialHead of the Impactor / Extractor andpush upward toward the UHR® headcenter. This spreads the locking ringwithin the UHR® component. With agentle pulling action, remove theImpactor / Extractor Handle assemblyand the key from the constrained insertat the same time.

Head AssemblyGo back to page 5 and proceed with the instructions for final implant headassembly.

Figure 7

7

Option 2:

Cementing into the Acetabulum:To cement the Trident® All-PolyConstrained Insert directly into theacetabulum, the bone must first beproperly prepared. This is done throughspherical acetabular reaming.

Reaming

Acetabular reaming is initiated with a reamer size that fits easily into thesocket. This allows reaming based onthe anatomic center of the acetabulum.Initial reaming should be carried out to identify the medial wall. Reamingshould medialize the socket to thispoint but care should be taken not tocompromise or violate the medial wall.

NOTE: If too small a reamer is chosento begin with, the reaming process may begin eccentrically, thus removingexcessive anterior or posterior wall bonestock with resultant non-anatomicplacement of the acetabular component.

The low profile design of the CuttingEdge Spherical Reamer necessitates the

need to ream to the full depth. Thereamer head should be driven to thepoint where the rim/cross bar contactsthe acetabular wall at the peripherallunate region. Removal of the reamerfrom the handle is performed by pullingback on the locking sleeve and rotatingthe reamer head a quarter-turn in aclockwise direction.

NOTE: Care should be taken not toenlarge or distort the acetabulum byeccentric reaming. Final acetabularreaming ideally shows the hemisphericalacetabulum denuded of cartilage, withthe subchondral plate preferably intact,and the anterior acetabular wall pre-served.

It is believed that the subchondral platefunctions as an important load-sharingand support mechanism. Preserving asmuch of the subchondral plate as possiblemay help preserve the qualities of thebone/metal composite.

Reaming should be done to the desiredimplantation size.

NOTE: It is recommended to have a2mm cement mantle, so 4mm should

be added to the respective Trident®Constrained Insert Outer Bearing ODSpherical Diameter (see Table 3 on page2) to equal the implantation size (i.e., if you ream to 56mm, add cement andimplant the insert with a 52mm OD).

NOTE: The Cutting Edge SphericalReamers are very aggressive and performbest when sharp. Care should be takento protect the reamer from unnecessaryhandling, as dull or damaged cuttingteeth may cause improper reaming. Dullcutting teeth will resist hard bone andwill deflect to cut softer bone. This situ-ation may result in an irregularly shapedor enlarged acetabulum preparation.

Cement Fixation Holes

After completion of reaming, fixationholes may be made in the subchondralplate. These can be made with a flexibledrill and drill guide provided in theinstrument set, a curette, or a powerbur. A single primary fixation holeshould be created in each of three areas:the acetabular dome, ischial ramus, andpubic ramus. Additional holes can becreated at the surgeon’s discretion.

Trident® Constrained Acetabular Insert Trials

Trident® 0° Insert Trials Trident® 10° Insert Trials Trident® All-Poly Insert Trials

2270-22D 2230-22E 1090-2244

2270-22E 2230-28F 1090-2246

2270-28F 2230-28G 1090-2248

2270-28G 2230-28H 1090-2850

2270-32H 2230-28I 1090-2852

2270-32I 2230-28J 1090-2854

2270-32J 1090-3256

1090-3258

1090-3260

Drivers (included in Bone Screw Tray)

Straight Driver Shaft 2107-1014Universal Driver Shaft 2107-1015Flexible Driver Shaft 2107-1016Straight Driver Shaft - 6" 2107-1017Captive Twist Straight Driver Shaft 2107-2014

Ratchet Handle for Drivers 2107-1000

Trident® Constrained Acetabular Inserts utilize theCutting Edge Bone Screw Tray and Acetabular Reamer Tray

8

Trialing

Trialing can be accomplished by usingthe respective Insert Trial. The inserttrials are the same size as the actualimplant and do not take into accountthe cement mantle. The trials shouldalso be used to assess the fit and esti-mate final orientation of the cup priorto implantation.

NOTE: To maintain a 2mm cementmantle, a trial 4mm greater than thefinal implant may be used to assessreaming depth. Take care to note theassociated head size of the larger trial.

Cementing and Inserting Implant

Once trial reduction is complete, theinsert can now be cemented in place.

Method One

If using the 2199-20XX Impactor Tip –Thread the Constrained Liner Inserter/Impactor Tip onto the Trident® CupImpactor handle. Place the anteversionrod in the correct position.

If using the 2199-20XX Rev. C orgreater Impactor Tip – Thread themetal adapter onto the tip. Load the tipinto the Insert Positioner / ImpactorHandle.

Mount the selected Trident® All-PolyConstrained Insert on the inserter tip.Mix one pack of Simplex bone cementaccording to the manufacturer’s specifi-cations and lavage the inside of theacetabulum. Dry thoroughly prior to theintroduction of the bone cement. Thecement is mixed and is inserted into theacetabulum in bolus form. Once it hasachieved a doughy state, the insert,mounted on the inserter tip, is thenpressed gently into the cup and drivendeeply into the bed of cement. The angleguide allows assessment of proper cupposition, which is typically 40 to 45degrees of abduction or lateral openingand 10 to 20 degrees of anteversion.

NOTE: When determining the properangulation of the insert, it is important tocritically evaluate the anatomic landmarksand patient anatomy for optimumplacement.

It is essential that the insert be com-pressed into the acetabulum and theinserter held as still as possible untilcement has hardened. After the cementis cured, the inserter tip is then carefullyremoved from the insert. Take specialmeasures to remove all excess bonecement from the edges of the cup by utilizing curettes and osteotomes.

Method Two

Select a Threaded Trial Head (1205-0022/ 1205-0028 / 1205-0032) with the sameouter diameter as the inner diameter ofthe chosen constrained insert. Also,select an appropriately sized HeadRemoval Key (HI-UHRK-3638 / HI-UHRK-28 / HI-UHRK-32).

WARNING: Ensure the Head RemovalKey is available to remove theThreaded Trial Head before proceeding.

Assemble the Howmedica OsteonicsThreaded Trial Head onto theHowmedica Osteonics ThreadedImpactor/Extractor Handle (2101-0004).

Once assembled, insert the ThreadedTrial Head into the bipolar componentof the constrained insert. Mix one packof Simplex™ bone cement according tothe manufacturer’s specifications andlavage the inside of the cup shell. Drythoroughly prior to introduction of thebone cement. The cement is mixed andis inserted into the acetabular shell in

bolus form. Once it has achieved adoughy state, the insert, mounted on theintroducer (Impactor / ExtractorHandle Assembly), is then pressed gen-tly into the cup and driven deeply intothe bed of cement.

NOTE: When determining the properangulation of the insert, it is importantto critically evaluate the anatomic land-marks and patient anatomy for opti-mum placement.

It is essential that the insert be com-pressed into the cup and the introducer(Impactor / Extractor Handle Assembly)held as still as possible until cement hashardened. After the cement is cured, theinsert introducer (Impactor / ExtractorHandle Assembly) is then carefullyremoved from the insert with the select-ed Head Removal Key. Take specialmeasures to remove all excess bonecement from the edges of the cup byutilizing curettes and osteotomes.

Use of the Head Removal Key

Insert the Head Removal Key into theinner bearing area between the bipolarcomponent and the Threaded TrialHead of the Impactor / Extractor andpush upward toward the UHR® headcenter. This spreads the locking ringwithin the UHR® component. With agentle pulling action, remove theImpactor / Extractor Handle assemblyand the key from the constrained insertat the same time.

Femoral Bearing Head/InsertAssemblySee page 5 for the instructions to per-form the final implant head assembly.

9

Additional Required Instruments

Femoral Stem Head Impactor 1104-1000Head Removal Key 22MM Inner Diameter HI-UHRK-3638Head Removal Key 28MM Inner Diameter HI-UHRK-28Head Removal Key 32MM Inner Diameter HI-UHRK-32Trident® Cup Impactor 2101-0200Constrained Liner Inserter/Impactor Tip 2199-2022Constrained Liner Inserter/Impactor Tip 2199-2028Constrained Liner Inserter/Impactor Tip 2199-2032Threaded Trial Head 22mm (3/pk) 1205-0022Threaded Trial Head 28mm (3/pk) 1205-0028Threaded Trial Head 32mm (3/pk) 1205-0032Threaded Impactor / Extractor Handle 2101-0004Command Femoral Head Impactor 6266-0-140Insert Positioner / Impactor Handle 2111-0000B

Cases and Trays

Trident® 0° and All-Poly Constrained Insert Trial Tray/Case 2402-3020Trident® 0° and All-Poly Constrained Insert Trial Lid 2402-3090

Double Tier Case 8000-0200Single Tier Case 8000-0100Trident® 10° Constrained Insert Trial Tray 2402-1100

The system provides the option of either a Single Tier or Double Tier Case.The Double Tier Case accommodates both the 10° Constrained Insert Trial Trayand the Eccentric Insert Trial Tray.

10

Indications,Contraindications andWarnings

DescriptionThe Trident® Constrained AcetabularInsert is comprised of two pre-assembledcomponents: an outer insert componentand a captured UHR® (Universal Head)component. The UHR® component iscomprised of an outer shell into which a bearing insert has been permanentlyassembled. The UHR® bearing insert has a factory assembled UHMWPEretention ring. The outer acetabularinsert has a Ti alloy retaining ringwhich retains the UHR® head in theplastic portion of the insert. With theexception of the Trident® All-PolyConstrained Inserts, the Trident®Constrained Acetabular Inserts aredesigned to be assembled with Trident®metal acetabular shells. The Trident® All-Poly Constrained Inserts can becemented directly into a GAP Cup, GAPRing, Trident® metal acetabular shell, or directly into the acetabulum. Theassembled acetabular component is used in conjunction with anyappropriately sized HowmedicaOsteonics stem of compatible head size, to achieve total reconstructivereplacement of the hip joint.

Warnings and PrecautionsSee package insert for warnings,precautions, adverse effects and otheressential product information.

Indications• The Trident® Constrained Acetabular

Insert is indicated for use as acomponent of a total hip prosthesis inprimary and revision patients at highrisk of hip dislocation due to a historyof prior dislocation, bone loss, joint or soft tissue laxity, neuromusculardisease, or intraoperative instability.

Contraindications• Bone or musculature compromised

by disease, infection or priorimplantation, which cannot provideadequate support or fixation for the prosthesis.

• Infection in or about the hip joint.

• Skeletal immaturity.

11

Notes

12

Notes

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use aparticular product when treating a particular patient. Stryker does not dispense medical advice and recommendsthat surgeons be trained in the use of any particular product before using it in surgery.The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon mustalways refer to the package insert, product label and/or instructions for use before using any Stryker product.Products may not be available in all markets because product availability is subject to the regulatory and/or medicalpractices in individual markets. Please contact your Stryker representative if you have questions about theavailability of Stryker products in your area.The products listed above are CE marked according to the Medical Device Directive 93/42/EEC.Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the followingtrademarks or service marks: Accolade, Cutting Edge, LFIT, PCA, Simplex, Stryker, TMZF, Trident, UHR, V40. Allother trademarks are trademarks of their respective owners or holders. Literature Number: LSP44 Rev. 3MS/GS 03/12Copyright © 2012 StrykerPrinted in USA

325 Corporate DriveMahwah, NJ 07430t: 201 831 5000

www.stryker.com