ECHELON PRIMAR Y HIP SYSTEM - Smith & Nephew...Echelon revision implants. IMPLANT REAMING CHART 10...

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S U R G I C A L T E C H N I Q U E E C H E L O N ® P R I M A R Y H I P S Y S T E M

Transcript of ECHELON PRIMAR Y HIP SYSTEM - Smith & Nephew...Echelon revision implants. IMPLANT REAMING CHART 10...

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

E C H E L O N ® P R I M A R Y H I P S Y S T E M

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Broach and Trial

Implant Stem

Basic Steps

Ream to Size

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Echelon Primary Hip System Surgical Technique

Harry B. Skinner, M.D., Ph.D.Professor and Chairman

Department of Orthopaedic Surgery

University of California, Irvine

Orange, California

James P. Waddell, M.D., F.R.C.S.(C)A.J. Latner Professor & Chairman

Division of Orthopaedic Surgery

University of Toronto

Toronto, Ontario, Canada

Nota Bene: The technique description herein is made available to the healthcare professional to illustrate

the authors’ suggested treatment for the uncomplicated procedure. In the final analysis,

the preferred treatment is that which addresses the needs of the patient.

®

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STANDARD OFFSET

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Porous Femoral Implants

DRIVING PLATFORM – The Echelon implants feature a threaded drivingplatform with an elliptical slot for rotational andaxial implant control during insertion.

NECK GEOMETRY – Circulotrapezoidal neck providesincreased range of motion compared to a circular neck of the same strength. Polished surface improves fatigue strength.

LATERAL PROXIMAL FLARE – Echelon has a 3̊ proximal anterior/posterior flare to improve proximal fill, without preventing implant seating.

DISTAL BULLET TIP – The bullet tip reduces the stressbetween the distal implant tip and the bone to minimize end-of-stem thigh pain.

OPTIMIZED 12/14 TAPER – Modular femoral heads are lockedon to the stem with an optimized12/14 taper which contributes to an increased range of motion.

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SIZE RANGE – Echelon Primary stems are offered in 1 mm increments to minimize bone removal and provide optimum canal fill.

HIGH OFFSET

POROUS COATING – RoughCoat™ porous coating increases the friction between the implant and bone,improving implant stability and providing a porous surface for bone ingrowth.

SHOULDER RELIEF – The lateral shoulder is rounded to minimize the risk of fracturing the greater trochanter during stem insertion.

NECK OFFSET OPTIONS – Standard and high offset options areavailable to ensure the appropriatejoint tension.

DISTAL FLUTES – The Echelon system offers distal flutes to increase rotational stability

DISTAL SLOT – The distal slot eases stem insertion,reduces the risk of fracture and reducesdistal stem stiffness.

MATERIAL – All Echelon implants are manufacturedfrom Cobalt Chromium allowing forextensive porous coating of the stem.

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General Specifications:

Cobalt Chromium Material

Neck Shaft Angle 131˚

Standard Collar Shaft Angle 50˚

Primary Stem Length 130-160 mm*

Porous Coating Length 90-108 mm**

The broach is .5 mm smaller than the implant.

Distal flute diameter is .25 mm larger than porous coated cylindrical diameter.

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

** Porous coating length is measured from the shoulder to the distal end of the coating.

NECK LENGTH (mm)

Size –3 +0 +4 +8 +12 +16

11-12 24 28 27 31 31 35 35 39 39 43 43 47

13-14 27 33 30 36 34 40 38 44 42 48 46 52

15-17 31 36 34 39 38 43 42 47 46 51 50 55

18-19 34 39 37 42 41 46 45 50 49 54 53 58

NECK OFFSET (mm)

Size –3 +0 +4 +8 +12 +16

11-12 32 38 34 40 37 43 40 46 43 49 46 52

13-14 35 43 37 45 40 48 43 51 46 54 49 57

15-17 38 46 40 48 43 51 46 54 49 57 52 60

18-19 41 49 43 51 46 54 49 57 52 60 55 63

NECK HEIGHT (mm)

Size –3 +0 +4 +8 +12 +16

11-12 25 25 27 27 30 30 32 32 35 35 37 37

13-14 28 28 30 30 33 33 35 35 38 38 40 40

15-17 30 30 32 32 35 35 37 37 40 40 42 42

18-19 34 34 36 36 39 39 41 41 44 44 46 46

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Implant Specifications

STANDARDOFFSET

HIGHOFFSET

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Stem

Leng

th-1

30-1

60 m

m

Poro

us C

oati

ng L

engt

h—

90-

108

mm

Neck Length

Neck Offset

Nec

k H

eigh

t

Standard/ PorousHigh Offset Stem Coating

Size Length Length

11-12 130 mm 90 mm

13-14 140 mm 96 mm

15-17 150 mm 102 mm

18-19 160 mm 108 mm

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Implant Specifications

Stem Size (11-19 mm)

Stem Size + .25 mm

LENGTH MEASUREMENTS

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Pre-op Planning

Pre-operative planning is essential to ensureappropriate implant selection and reaming. It may also be valuable in determiningmanagement of leg length discrepancy. Both standard offset and high offset implantsare available and templates for these implantsshould be utilized to determine the optimumoffset for each individual patient.

Both an anteroposterior radiograph of thepelvis with the hips in neutral rotation and alateral hip radiograph optimize pre-operativetemplating. The proximal one-third of thefemur should be visible on these radiographs.

In order to determine appropriate offset and management of leg length discrepancy, it is necessary that the femoral templates be utilized in conjunction with acetabulartemplates appropriate for the implant that has been selected for the acetabularreconstruction.

The femoral templates provided allow for different neck offset options in addition to varying head depths and head diameters toensure comprehensive selection of implants to deal with variations in femoral and acetabular anatomy.

130 mm

34 mm

40 mm

27 mm

12 mm

12.25 mm

+16+12+ 8+ 4+ 0

–3

*

*

131ºNECK

ANGLE

Standard Offset: 27 mmHigh Offset: 31 mm

P O R O U S P R I M A R Y S T E M

¨-

SIZE 12120% MAGNIFICATION

–3 and +16 femoral heads available in 28 mm and 32 mm only.

For use with Smith & Nephew 12/14 femoral heads only.

*Skirted Femoral Heads

NECK LENGTH

E C H E L O N ® P O R O U S P R I M A R Y S T E M S I Z E 1 2

Echelon is a trademark of Smith & Nephew, Inc. ©-2000 Smith & Nephew, Inc., Memphis, Tennessee. 02/00 7138-0648

20

10

0

10

20

30

40

50

60

70

80

90

100

110

120

130

140

150

160

MM50

40

30

FEMORAL HEADS

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Femoral Neck Osteotomy

1. The point of the femoral neck resection should be marked with the electrocautery corresponding to both the preoperative templating and the intraoperative measurement.This will confirm that the level of thefemoral neck resection is appropriateand will re-establish the desired leglength of the proximal femur.

An osteotomy guide is available for proximal bone resection. Resectthe proximal bone by cutting through the angled slot. The osteotomy guidehas a vertical scale in 5 mm incre-ments to help gauge neck height.Osteotomize the femoral neck (Figures 1A and 1B).

Figure 1A

Figure 1B

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Acetabular and Femoral Canal Preparation

2. The acetabulum should be prepared in the recommended fashion for theacetabular component to be utilizedaccording to pre-operative planning and templating.

3. Remove remnants of the femoral neckand open the medullary canal using the box osteotome (Figure 3A). Usethe canal finder and modular T-handlefor initial femoral reaming (Figure 3B).

NOTE: It is important to stay lateral withboth the box osteotome and canal finder.Care should be taken to ensure that the initial reaming track into the femur is inneutral alignment with the femoral axis.

Do not pressurize intramedullary contentswith canal finder by inserting too rapidly.

Figure 3B

Figure 3A

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4. Rigid femoral reamers in 0.5 mm increments are available.

The stem size is measured at the maximum diameter of the distal porous coating. Themaximum diameter of the flutes is .25 mmlarger than the diameter of the porous coating.

Start reaming with a reamer 4 to 6 mm smallerthan the templated size or a reamer that haslittle or no resistance in the femoral canal.

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

NOTE: The flutes on the distal stem are .25 mmlarger than the porous coated diameter. Therefore,reaming line-to-line will produce a .25 mm pressfit in the distal fluted region of the stem.

The stem length is measured from the collar tothe distal tip of the implant. Reaming depth isalso measured from the collar to the distal tipof the implant (Figure 4A and Figure 4B).Use the implant reaming chart to determinethe reaming depth for the porous implants.Seat the reamer to the appropriate depth mark on each reamer.

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Femoral Reaming

Ream Depth from Stem Medial Resection Level

11-12 130 mm

13-14 140 mm

15-17 150 mm

18-19 160 mm

Figure 4B

Figure 4A

Stem Size

11-1

2 m

m R

eam

Dep

th 1

30 m

m

18-1

9 m

m R

eam

Dep

th 1

60 m

m

NOTE: Echelon reamers havemultiple depth marks. The distal-most mark indicates the Primary stem reamingdepth. Other depth markingsindicate reaming depths forEchelon revision implants.

IMPLANT REAMING CHART

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Femoral Broaching & Calcar Preparation

5. Attach the broach handle to the femoral broach and begin broaching two sizes smaller than the size of the last femoral reamer (Figure 5). The final broach should match the size of the selectedimplant. The femoral broaches are 0.5 mm smallerthan the porous coating level of the implant.

Be sure to stay lateral with the smaller broaches to avoid varus broaching.

6. A calcar reamer is available. With the finalbroach fully seated, remove the broach handle(Figure 6). Place the calcar reamer over thebroach post and ream the calcar flush with the top of the broach. This will ensure uniform contact between the collar of the prosthesis and the calcar. (This can be verified by placing the trial neck on the broach.)

Figure 5

Figure 6

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Trialing

7. After calcar reaming, place the matchingtrial neck onto the broach post (as deter-mined by pre-op templating). Place thedesired trial femoral head on the trial neck and reduce the hip to assess stability and range of motion (Figure 7).

Trial HeadColor 22 mm 26 mm 28 mm 32 mm

Green — — –3* –3*

Yellow +0* +0* +0* +0*

Red +4* +4* +4* +4*

White +8* +8* +8* +8*

Blue +12* +12* +12* +12*

Black — — +16* +16*

*Skirted Femoral Head

FEMORAL NECK LENGTH OPTIONS

Figure 7

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Trial Reduction

1. SOFT TISSUE TENSION – Some shuck is normal when applying a longitudinaldistraction force to the hip. Shuck should not be excessive, and the hip should not dislocate (Figure 8A).Rectus femoris tightness (hip in extension, knee flexed) should be no tighter than pre-op.

2. ANTERIOR STABILITY – Place the leg in full abduction, full extension andhyperextension, while exerting an externalrotation force. If the hip cannot be fullyextended, it may be too tight. If it dislocateseasily, it is too loose and impingement mustbe addressed or component malpositionexists (Figure 8B).

3. POSTERIOR STABILITY – Place the leg in neutral adduction and 90° flexion.Gradually rotate internally. If it dislocateswith minimal internal rotation, it is too loose and impingement must be addressed orcomponent malposition exists (Figure 8C ).

4. SLEEP POSITION – Place the leg in the“sleep position” with the operated leg semiflexed, adducted and internally rotatedover the other leg. Apply axial force to try to dislocate. This position represents a dangerous unstable position that may be adopted by a patient sleeping on their nonoperated side (Figure 8D).

5. COMBINED COMPONENT POSITIONING –

Place the leg in neutral extension andadduction. Internally rotate the hip 45º. Cup should cover the “northern hemisphere”of the head. This position is an additionaltest of the positioning of the components in relation to each other.

Reduce the hip and evaluate in the following ways:

Figure 8A

Figure 8B

Figure 8C

Figure 8D

8.

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Implant Insertion

Assemble the threaded stem inserter by inserting the stem inserter pommel through the stem inserter frame. Stand the stem inserter upright so that the threaded tip is pointed up (Figure 9A). Screw the implant onto the threaded tip as far as possible.

Flip the assembly over so that the stem tip is now pointing down (Figure 9B).Engage the frame tine into the slots adjacent to the threaded hole on the stem. Screw the pommel until assembly is secure (Figure 9C).Fully tighten the pommel before impaction.

Stem version can be accurately measured by attaching the anteversion handle to the stem inserter frame. This not only allows accurate visualization of anteversion, but will help control rotation of the stem during impaction.

9.

Figure 9C

Figure 9B

Figure 9A

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Implant Insertion

10. Insert the implant into the canal with handpressure and verify proper implant version. Use firm mallet blows to seat the implant to the desired level (Figure 10).

NOTE: Once the implant flutes have engaged the bone, the implant version cannot be changed without remov-ing the implant. The implant can be removed by strikingthe underside of the threaded stem driver with a mallet.

Figure 10

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Implant Trialing & Femoral Head Assembly

Once the implant is fully seated, perform a finaltrial reduction to determine appropriate necklength. Place the desired trial femoral head on the implant and reduce the hip to assess stabilityand range of motion (Figure 11).

Clean and dry the taper with a sterile cloth, placethe prosthetic femoral head on the neck taper andfirmly impact several times with a femoral headimpactor and a mallet (Figure 12).

11.

12.

Figure 11

Figure 12

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Conclusion

Irrigate the wound and maintainappropriate hemostasis. If desired,repair the hip capsule and overlyingtendons. Close the deep fascial layers,subcutaneous tissue and skin.

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Catalog Information

Femoral ImplantsStandard High

Size Offset Offset

11 7134-1011 —12 7134-1012 7134-102213 7134-1013 7134-102314 7134-1014 7134-102415 7134-1015 7134-102516 7135-1016 7134-102617 7134-1017 7134-102718 7134-1018 7134-102819 7134-1019 7134-1029

StandardOffset

HighOffset

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

Neck Length 22 mm 26 mm 28 mm 32 mm

–3 — — 7130-2803 7130-3203+0 7130-2200 7130-2600 7130-2800 7130-3200+4 7130-2204 7130-2604 7130-2804 7130-3204+8 7130-2208 7130-2608 7130-2808 7130-3208

+12 7130-2212 7130-2612 7130-2812 7130-3212+16 — — 7130-2816 7130-3216

Zirconia 12/14 Taper Femoral HeadsNeck Length 22 mm 26 mm 28 mm

+0 — 7132-0026 7132-0028+4 7132-0422 7132-0426 7132-0428+8 7132-0822 7132-0826 7132-0828

Trial 12/14 Taper Femoral HeadsNeck Color

Length Code 22 mm 26 mm 28 mm 32 mm

–3 Green — — 7135-2803 7135-3203+0 Yellow 7135-2200 7135-2600 7135-2800 7135-3200+4 Red 7135-2204 7135-2604 7135-2804 7135-3204+8 White 7135-2208 7135-2608 7135-2808 7135-3208

+12 Blue 7135-2212 7135-2612 7135-2812 7135-3212+16 Black — — 7135-2816 7135-3216

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Echelon Starter TrayCat. No. 7136-6001

Osteotomy GuideCat. No. 7136-4100

Box OsteotomeCat. No. 7136-4002

Femoral Canal FinderCat. No. 7136-4001

T-Handle(2 per set)Cat. No. 7136-4006

Broach Handle(2 per set)Cat. No. 7136-4007

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

Proximal Reamer Cat. No. 7136-4015

Echelon Reamer TrayCat. No. 7136-6002

Rigid Reamer Cat. No. Size

7135-0090 9 mm7135-0095 9.5 mm7135-0100 10 mm7135-0105 10.5 mm7135-0110 11 mm7135-0115 11.5 mm7135-0120 12 mm7135-0125 12.5 mm7135-0130 13 mm7135-0135 13.5 mm7135-0140 14 mm7135-0145 14.5 mm7135-0150 15 mm7135-0155 15.5 mm7135-0160 16 mm7135-0165 16.5 mm7135-0170 17 mm7135-0175 17.5 mm7135-0180 18 mm7135-0185 18.5 mm7135-0190 19 mm7135-0195 19.5 mm7135-0200 20 mm

Catalog Information

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Catalog Information

Broach TrayCat. No. 7136-6003

Broach Cat. No. Size

7136-7010 107136-7011 117136-7012 127136-7013 137136-7014 147136-7015 157136-7016 167136-7017 177136-7018 187136-7019 197136-7020 20

Calcar ReamerCat. No. 7136-4004

Stem Inserter FrameCat. No. 7136-4008

Stem Inserter PommelCat. No. 7136-4011

Femoral Head ImpactorCat. No. 7136-4009

Trial NeckStandard High

Size Offset Offset

11-12 7136-7201 7136-722113-14 7136-7202 7136-722215-17 7136-7203 7136-722318-19 7136-7204 7136-7224

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IMPORTANT NOTETotal hip replacement arthroplasty has become a successful procedurefor relieving pain and restoring motion in patients who are disabledfrom hip arthropathy. The goals of total hip replacement are todecrease pain, increase function, and increase mobility.

MATERIALSThe Total Hip System is manufactured from materials as outlinedbelow. The component material is provided on the outside carton label.

Component Material Material StandardsFemoral Components Ti-6Al-4V ASTM F 136 and ISO 5832/3 or

or ASTM F 1472 and ISO 5832/3Co-Cr-Mo or

ASTM F 799 and ISO 5832/12orASTM F 75 and ISO 5832/4

Acetabular shells Ti-6Al-4V ASTM F 1472 and ISO 5832/3Proximal padsTaper sleevesDistal sleevesFixation screws and pegsHole coversAcetabular components UHMWPE ASTM F 648Acetabular linersFemoral centralizers PMMA Not applicableAcetabular spacer podsX-ray marking wire Co-Cr-Mo ASTM F 90 and ISO 5832/5Acetabular Reconstruction CP Titanium ASTM F 67 and ISO 5832/2RingAcetabularReinforcement RingFemoral Heads Co-Cr-Mo ASTM F 799 and ISO 5832/12

Zirconia ISO 13356Ceramic

Porous titanium components and porous Co-Cr-Mo components arecoated with commercially pure (C.P.) titanium beads (ASTM F 67 andISO 5832/2) and Co-Cr-Mo beads (ASTM F 75), respectively.Hydroxylapatite coatings include HA (ASTM F 1185) that is appliedeither on a grit blasted or porous surface. NOTE: HA coated porousimplants are not available in the USA.

Zirconia ceramic femoral heads are yttria stabilized zirconia ceramic.

Some of the alloys needed to produce orthopedic implants containsome metallic components that may be carcinogenic in tissue culturesor intact organisms under very unique circumstances. Questions havebeen raised in the scientific literature as to whether or not these alloysmay be carcinogenic in implant recipients. Studies conducted to eval-uate this issue have not identified conclusive evidence of such phe-nomenon, in spite of the millions of implants in use.

DESCRIPTION OF SYSTEMThe Total Hip System consists of femoral components, proximalpads, taper sleeves, distal sleeves, acetabular components, fixationscrews and pegs, hole covers, centralizers, and femoral heads.Components may be grit blasted, porous coated, hydroxylapatite(HA) coated, or HA porous coated. All implantable devices aredesigned for single use only.

Femoral ComponentsFemoral components are available in a variety of sizes. Porous coatedcomponents are coated for biological ingrowth. Proximally and distallymodular femoral components accept proximal pads and distal sleeves,respectively. Non-porous femoral components can feature PMMA cen-tralizers that help produce a uniform thickness of cement in a concen-tric manner.

Femoral components are available with a small, large (14/16), or12/14 global taper (gage diameters 0.404, 0.564, and 0.500 inches,respectively).

Small taper femoral components mate and lock directly with a 22 mmmetal or ceramic head. The small taper also mates with a tapersleeve which, in turn, mates with either metal or ceramic heads (26,28, or 32 mm), bipolar or unipolar components.

Large taper femoral components mate and lock with either metal heads(26, 28, or 32 mm), ceramic heads (22, 28 or 32 mm), bipolar or unipo-lar components.

Femoral components with a 12/14 taper mate and lock with eithermetal heads (22, 26, 28, or 32 mm), ceramic heads (26 or 28 mm),bipolar or unipolar components.

Small, large, and 12/14 taper femoral component tapers aremachined to mate and lock with ceramic heads, thus preventing rota-tion of the ceramic head on the stem, the latter would cause wear ofthe stem taper.

Taper SleevesA taper sleeve is required to be impacted on the small taper femoralcomponent prior to impacting a femoral head size 26, 28, or 32 mm. Ataper sleeve is required to attach a unipolar head. Unipolar tapersleeves are available in small, large, and 12/14 tapers. Never placemore than one taper sleeve on a femoral component.

Femoral HeadsCobalt chromium (22, 26, 28, and 32 mm) and ceramic (22, 26, 28, and32 mm) heads are available in multiple neck lengths for properanatomic and musculature fit. Heads are highly polished for reducedfriction and wear. The following zirconia ceramic heads are availablefor use only with small and large taper femoral components.

Zirconia HeadCeramic Diameter Neck Length42-7815 32 mm Standard 0 mm42-7816 32 mm Long 4 mm42-7817 32 mm X-Long 8 mm42-7818 28 mm Standard 0 mm42-7819 28 mm Long 4 mm42-7820 28 mm X-Long 8 mm

Note: 32 mm heads with a -3 mm neck length are not available for usewith the small taper stems.

In addition to the components listed above, the following componentsare available for use only with small taper femoral components

Zirconia HeadCeramic Diameter Neck Length

7132-0002 22 mm Long 4 mm7132-0006 22 mm X-Long 8 mm

Note: 22 mm Zirconia Ceramic Heads used with small taper femoralcomponents are not available in the USA.

The following zirconia ceramic heads are available for use only with12/14 taper femoral components:

Zirconia HeadCeramic Diameter Neck Length

7132-0028 28 mm 0 mm7132-0428 28 mm +4 mm7132-0828 28 mm +8 mm7132-0026 26 mm 0 mm7132-0426 26 mm +4 mm7132-0826 26 mm +8 mm7132-0422 22 mm +4 mm7132-0822 22 mm +8 mm

The following alumina ceramic heads are available for use only with12/14 taper femoral components:

Alumina HeadCeramic Diameter Neck Length

7133-2800 28 mm 0 mm7133-2804 28 mm +4 mm

*7133-2808* 28 mm +8 mm7133-3200 32 mm 0 mm7133-3204 32 mm +4 mm7133-3208 32 mm +8 mm

* The Alumina 28 mm +8 head size is not for use with a Co-Cr-Mo taperin the U.S.A.

Acetabular ComponentsAcetabular components can be one-piece, all-polyethylene or two-piececomponents consisting of a titanium shell and a polyethylene liner.Please see Warnings and Precautions for specific information onscrews, pegs and hole covers use. Acetabular reinforcement and recon-struction rings are used with an all polyethylene acetabular component.

Femoral components and femoral heads are designed for use with anySmith & Nephew polyethylene acetabular component or polyethylene-lined, metal-backed acetabular component having an appropriately-sized inside diameter.

INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTSHip components are indicated for individuals undergoing primary andrevision surgery where other treatments or devices have failed in reha-bilitating hips damaged as a result of trauma or noninflammatorydegenerative joint disease (NIDJD) or any of its composite diagnosesof osteoarthritis, avascular necrosis, traumatic arthritis, slipped capitalepiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative jointdisease including rheumatoid arthritis, arthritis secondary to a varietyof diseases and anomalies, and congenital dysplasia; old, remoteosteomyelitis with an extended drainage-free period, in which case, thepatient should be warned of an above normal danger of infection post-operatively; treatments of nonunion, femoral neck fracture andtrochanteric fractures of the proximal femur with heads involvementthat are unmanageable using other techniques; endoprosthesis,femoral osteotomy, or Girdlestone resection; fracture-dislocation of thehip; and correction of deformity.

Acetabular reinforcement and reconstruction rings are intended tobe used in primary and revision surgeries where the acetabulum has

the deficiencies of the acetabular roof, anterior or posterior pillar,medial wall deficiency, and / or protrusion as a result of the indica-tions listed previously.

Some of the diagnoses listed above and below may also increase thechance of complications and reduce the chance of a satisfactory result.

Contraindications1. Conditions that would eliminate or tend to eliminate adequate implant

support or prevent the use of an appropriately-sized implant, e.g.:

a. blood supply limitations;

b. insufficient quantity or quality of bone support, e.g., osteoporo-sis, or metabolic disorders which may impair bone formation,and osteomalacia; and

c. infections or other conditions which lead to increased boneresorption.

2. Mental or neurological conditions which tend to impair the patient'sability or willingness to restrict activities.

3. Physical conditions or activities which tend to place extreme loadson implants, e.g., Charcot joints, muscle deficiencies, multiple jointdisabilities, etc.

4. Skeletal immaturity.

5. The zirconia ceramic head is contraindicated for use with any otherproduct than an UHMW polyethylene cup or a metal backedUHMW polyethylene cup.

6. The alumina ceramic liner is contraindicated for use with any prod-uct other than the metal shell with the correlating inner taper geom-etry and the appropriate sized alumina ceramic head. The aluminaceramic liner should only be used with the alumina ceramic head.

Contraindications may be relative or absolute and must be carefullyweighted against the patient's entire evaluation and the prognosis forpossible alternative procedures such as non-operative treatment,arthrodesis, femoral osteotomy, pelvic osteotomy, resection arthro-plasty, hemiarthroplasty and others.

Conditions presenting increased risk of failure include: osteoporosis,metabolic disorders which may impair bone formation, and osteomalacia.

Possible Adverse Effects1. Wear of the polyethylene articulating surfaces of acetabular com-

ponents has been reported following total hip replacement. Higherrates of wear may be initiated by the presence of particles ofcement, metal, or other debris which can develop during or as aresult of the surgical procedure and cause abrasion of the articu-lating surfaces. Higher rates of wear may shorten the useful life ofthe prosthesis, and lead to early revision surgery to replace theworn prosthetic components.

2. With all joint replacements, asymptomatic, localized, progressivebone resorption (osteolysis) may occur around the prosthetic com-ponents as a consequence of foreign-body reaction to particulatewear debris. Particles are generated by interaction between com-ponents, as well as between the components and bone, primarilythrough wear mechanisms of adhesion, abrasion, and fatigue.Secondarily, particles may also be generated by third-body parti-cles lodged in the polyethylene articular surface. Osteolysis canlead to future complications necessitating the removal or replace-ment of prosthetic components.

3. Loosening, bending, cracking, or fracture of implant componentsmay result from failure to observe the Warnings and Precautionsbelow. Fracture of the implant can occur as a result of trauma,strenuous activity, improper alignment, or duration of service.

4. Dislocations, subluxation, decreased range of motion, or lengthen-ing or shortening of the femur caused by improper neck selection,positioning, looseness of acetabular or femoral components, extra-neous bone, penetration of the femoral prosthesis through the shaftof the femur, fracture of the acetabulum, intrapelvic protrusion ofacetabular component, femoral impingement, periarticular calcifi-cation, and/or excessive reaming.

5. Fracture of the pelvis or femur: post-operative pelvic fractures areusually stress fractures. Femoral fractures are often caused bydefects in the femoral cortex due to misdirected reaming, etc.Intraoperative fractures are usually associated with old congenitaldeformity, improper stem selection, improper broaching, and/orsevere osteoporosis.

6. Infection, both acute post-operative wound infection and late deepwound sepsis.

7. Neuropathies; femoral, sciatic, peroneal nerve, and lateral femoralcutaneous neuropathies have been reported. Temporary or perma-nent nerve damage resulting in pain or numbness of the affected limb.

8. Wound hematoma, thromboembolic disease including venousthrombosis, pulmonary embolus, or myocardial infarction.

9. Myositis ossificans, especially in males with hypertrophic arthritis,limited pre-operative range of motion and/or previous myositis.Also, periarticular calcification with or without impediment to jointmobility can cause decreased range of motion.

IMPORTANT MEDICAL INFORMATIONWarnings and Precautions

Total Hip System

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3434606 Rev. 0 8/99 CE0123

10. Trochanteric nonunion usually associated with early weight bearingand/or improper fixation of the trochanter, when a transtrochantericsurgical approach is used.

11. Although rare, metal sensitivity reactions and/or allergic reactionsto foreign materials have been reported in patients following jointreplacement.

12. Damage to blood vessels.

13. Traumatic arthrosis of the knee from intraoperative positioning ofthe extremity.

14. Delayed wound healing.

15. Aggravated problems of the affected limb or contralateral extremitycaused by leg length discrepancy, excess femoral mediatization, ormuscle deficiency.

16. Failure of the porous coating/ substrate interface or hydroxylapatitecoating/ porous coating bonding may result in bead separationdelamination.

17. Stem migration or subsidence has occurred in conjunction withcompaction grafting procedures usually resulting from insufficientgraft material or improper cement techniques. Varus stem align-ment may also be responsible.

WARNINGS AND PRECAUTIONSThe patient should be warned of surgical risks, and made aware ofpossible adverse effects. The patient should be warned that the devicedoes not replace normal healthy bone, that the implant can break orbecome damaged as a result of strenuous activity or trauma, and thatit has a finite expected service life and may need to be replaced in thefuture. Do not mix components from different manufacturers. AdditionalWarnings and Precautions may be included in component literature.

Preoperative1. Use extreme care in handling and storage of implant components.

Cutting, bending, or scratching the surface of components can sig-nificantly reduce the strength, fatigue resistance, and/or wear char-acteristics of the implant system. These, in turn, may induceinternal stresses that are not obvious to the eye and may lead tofracture of the component. Implants and instruments should be pro-tected from corrosive environments such as salt air during storage.Do not allow the porous surfaces to come in contact with cloth orother fiber-releasing materials.

2. Allergies and other reactions to device materials, although infre-quent, should be considered, tested for (if appropriate), and ruledout preoperatively.

3. Fixation and expected longevity of components expected to be leftin place at revision surgery should be thoroughly assessed.

4. Surgical technique information is available upon request. The sur-geon should be familiar with the technique.

5. Intraoperative fracture or breaking of instruments can occur.Instruments which have experienced extensive use or excessiveforce are susceptible to fracture. Instruments should be examinedfor wear, or damage, prior to surgery.

6. Do not cold water quench ceramic components and never sterilizeceramic heads while fixed on the stem taper. (See sterilization sec-tion, below.)

7. Select components such that the Zirconia ceramic head alwaysarticulates with a UHMW polyethylene cup or a metal backedUHMW polyethylene cup. Zirconia ceramic should never articulateagainst metal because severe wear of the metal will occur.

8. Select only Smith & Nephew femoral components that indicatetheir use with ceramic heads. This is important because the taperon the stem is machined to tightly mate and lock with the ceramichead thus preventing rotation of the ceramic head on the stem.Also, an improperly dimensioned taper could result in fracture ofthe ceramic head.

9. The zirconia ceramic head is composed of a new ceramic materialwith limited clinical history. Although mechanical testing demon-strates that when used with a polyethylene acetabular component,the yttria stabilized zirconia ball produces a relatively low amountof particulates, the total amount of particulate remains undeter-mined. Because of the limited clinical and preclinical experience,the biological effect of these particulates can not be predicted.

10. Alumina ceramic should never articulate against metal becausesevere wear could occur.

Intraoperative1. The general principles of patient selection and sound surgical judg-

ment apply. The correct selection of the implant is extremely impor-tant. The appropriate type and size should be selected for patientswith consideration of anatomical and biomechanical factors suchas patient age and activity levels, weight, bone and muscle condi-tions, any prior surgery and anticipated future surgeries, etc.Generally, the largest cross-section component which will allowadequate bone support to be maintained is preferred. Failure touse the optimum-sized component may result in loosening, bend-ing, cracking, or fracture of the component and/or bone.

2. Correct selection of the neck length and cup, and stem position-ing, are important. Muscle looseness and/or malpositioning ofcomponents may result in loosening, subluxation, dislocation,and/or fracture of components. Increased neck length and varuspositioning will increase stresses which must be borne by thestem. The component should be firmly seated with the compo-nent insertion instruments.

3. Care should be taken not to scratch, bend (with the exception ofthe Reconstruction Rings) or cut metal components during surgeryfor the reasons stated in Number One of the "Preoperative" sectionof "Warnings and Precautions."

4. A +12 mm or +16 mm femoral head should not be used withany small taper stems.

5. Distal sleeves should not be used to bridge cortical defectsthat lie within 25 mm of the tip of the base stem.

6. Matrix small taper stem sizes 8SÐ10L must have a minimum necklength of +8 mm when used with a bipolar component; and smalltaper stem sizes 12SÐ16L must have a minimum neck length of +4 mm when used with a bipolar component.

7. Modular heads and femoral components should be from the samemanufacturer to prevent mismatch of tapers.

8. Clean and dry stem taper prior to impacting the femoral head ortaper sleeve. The modular femoral head component must be firmlyseated on the femoral component to prevent disassociation.

9. Take care, when positioning and drilling screw and peg holes, toavoid penetration of the inner cortex of the pelvis, penetration of thesciatic notch, or damage to vital neurovascular structures.Perforation of the pelvis with screws that are too long can ruptureblood vessels causing the patient to hemorrhage. Do not place ascrew in the center hole of the acetabular prosthesis.

Placement of drills and screws in the anterior or medial portions ofthe prosthesis is associated with a high risk of potentially fatal vas-cular injury.

Bone screws must be completely seated in the holes of the shell toallow proper locking for the acetabular component liner. If thetapered pegs need to be removed from the shell after impaction ofthe pegs, do not reuse the pegs or the peg shell holes. Use newpegs and different shell holes, or a new shell if necessary.

10. USE ONLY REFLECTION¨ TITANIUM BONE SCREWS, UNIVER-SAL CANCELLOUS BONE SCREWS, TAPERED PEGS, ANDHOLE COVERS with the Reflection Acetabular Component andUSE ONLY OPTI-FIX¨ TITANIUM BONE SCREWS AND UNIVER-SAL CANCELLOUS BONE SCREWS with the Opti-Fix AcetabularComponent. The Reflection Interfit and the Reflection For ScrewsOnly (FSO) shells accept Universal Cancellous, Reflection screws,and tapered screw-hole covers, not pegs. Tapered pegs can onlybe used with Reflection V Shells. The threaded center hole inReflection Shells only accepts the threaded hole cover, not screwsor pegs. The InterFit threaded hole cover is only for use withReflection Interfit. The Reflection threaded hole cover can be usedwith both Reflection and InterFit shells. Refer to product literaturefor proper adjunctive fixation and hole cover usage.

11. Prior to seating modular components, surgical debris including tis-sue must be cleaned from the surfaces. Debris, including bonecement, may inhibit the component locking mechanism. If the shellis to be cemented in place, remove extraneous cement with a plas-tic sculps tool to ensure proper locking of the liner. During linerinsertion, make sure soft tissue does not interfere with theshell/liner interface. Chilling the liner reduces the impaction forcerequired to seat the liner. Modular components must be assembledsecurely to prevent disassociation. Debris inhibits the proper fit andlocking of modular components which may lead to early failure ofthe procedure. Failure to properly seat the acetabular liner into theshell can lead to disassociation of the liner from the shell.

12. Avoid repeated assembly and disassembly of the modular compo-nents which could compromise the critical locking action of thelocking mechanism.

13. Care is to be taken to assure complete support of all parts of the deviceembedded in bone cement to prevent stress concentration which maylead to failure of the procedure. During curing of the cement, careshould be taken to prevent movement of the implant components.

14. If components are to be left in place at revision surgery, they shouldfirst be thoroughly checked for signs of looseness, etc. andreplaced if necessary. The head/neck component should bechanged only when clinically necessary.

15. Once removed from the patient, implants previously implantedshould never be reused, since internal stresses which are not visi-ble may lead to early bending or fracture of these components.

16. With the congenitally dislocated hip, special care should be takento prevent sciatic nerve palsy. Also, note that the femoral canal isoften very small and straight and may require an extra-smallstraight femoral prosthesis; however, a regular-sized prosthesisshould be used when possible. Note that the true acetabulum isrudimentary and shallow. A false acetabulum should not ordinarilybe utilized as a cup placement site for anatomical and biomechan-ical reasons.

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

18. Revision procedures for previous arthroplasty, Girdlestone, etc., aretechnically demanding and difficult to exercise. Common errorsinclude misplacement of the incision, inadequate exposure or mobi-lization of the femur, inadequate removal of ectopic bone, orimproper positioning of components. Postoperative instability aswell as excessive blood loss can result. In summary, increasedoperative time, blood loss, increased incidence of pulmonary embo-lus and wound hematoma can be expected with revision proce-dures.

19. Prior to closure, the surgical site should be thoroughly cleaned ofcement, bone chips, ectopic bone, etc. Ectopic bone and/or bonespurs may lead to dislocation or painful or restricted motion.Range of motion should be thoroughly checked for early contactor instability.

20. When using a ceramic liner and metal shell, proper shell and liner

alignment and positioning are critical to implant performance. Ifthe ceramic liner and shell are not fully seated or are alignedincorrectly and final impaction, it will be necessary to revise theshell and liner with new components. An improper impaction willdamage the shell and liner taper which can increase the chanceof subsequent liner fracture or other component failure. Refer tothe surgical technique for specific information on shell assemblyand the implantation method.

21. Proper positioning of the components is important to minimizeimpingement which could lead to early failure, premature wear,and/or dislocation.

Postoperative1. Postoperative directions and warnings to patients by physicians,

and patient care, are extremely important. Gradual weight bearingis begun after surgery in ordinary total hip arthroplasty. However,with trochanter osteotomy or certain complex cases, weight-bear-ing status should be individualized with the non or partial weight-bearing period extended.

2. Patients should be warned against unassisted activity, particularlyuse of toilet facilities and other activities requiring excessive motionof the hip.

3. Use extreme care in patient handling. Support should be providedto the operative leg when moving the patient. While placing thepatient on bedpans, changing dressings, and clothing, and similaractivities, precautions should be taken to avoid placing excessiveload on the operative part of the body.

4. Postoperative therapy should be structured to regain musclestrength around the hip and a gradual increase of activities.

5. Periodic x-rays are recommended for close comparison with imme-diate postoperative conditions to detect long-term evidence ofchanges in position, loosening, bending and/or cracking of compo-nents or bone loss. With evidence of these conditions, patientsshould be closely observed, the possibilities of further deteriorationevaluated, and the benefits of early revision considered.

6. Prophylactic antibiotics should be recommended to the patient sim-ilar to those suggested by the American Heart Association for con-ditions or situations that may result in bacteremia.

PACKAGING AND LABELINGComponents should only be accepted if received by the hospital or sur-geon with the factory packaging and labeling intact.

STERILIZATION/RESTERILIZATIONMost implants are supplied sterile and have been packaged in protectivetrays. The method of sterilization is noted on the package label. All radi-ation sterilized components have been exposed to a minimum of 25 kiloGrays of gamma radiation. If not specifically labeled sterile, the implantsand instruments are supplied non-sterile and must be sterilized prior touse. Inspect packages for punctures or other damage prior to surgery.

Metal ComponentsNonporous metal components may be initially sterilized or resterilized,if necessary, by steam autoclaving in appropriate protective wrapping,after removal of all original packaging and labeling. Protect thedevices, particularly mating surfaces, from contact with metal or otherhard objects which could damage the product. The following processparameters are recommended for these devices:

· Prevacuum Cycle: 4 pulses (Maximum = 26.0 psig [2.8 bars] &Minimum = 10.0 inHg [339 millibars] with a minimum dwell time of 4minutes at 270¡F to 275¡F (132¡C to 135¡C), followed by a 1 minutepurge and at least 15 minutes of vacuum drying at 10 inHg (339 mil-libars) minimum.

· Gravity Cycle: 270¡F to 275¡F (132¡C to 135¡C) with a minimum dwelltime at temperature of 10 minutes, followed by a 1 minute purge andat least 15 minutes of vacuum drying at 10 inHg (339 millibars) mini-mum.

Smith & Nephew does not recommend the use of low temperaturegravity cycles or flash sterilization on implants.

Do not resterilize femoral prostheses with ceramic heads seated onthe stem.

If porous coated or HA coated implants are inadvertently contaminated,return the unsoiled prosthesis to Smith & Nephew for resterilization.DO NOT RESTERILIZE porous coated or HA coated implants. Theporous coating requires special cleaning procedures.

Plastic ComponentsPlastic components may be resterilized by ethylene oxide gas. The fol-lowing parameters are recommended as starting points for cycle vali-dation by the health care facility:

Sterilant Temp. Humidity Maximum Concen- Exposure Pressure tration Time

100% EtO 131ûF 40-80% 10 PSIA 725 60-180(55ûC) (70% Target) (689 millibar) mg/l minutes

Suggested initial starting point for aeration validation is 12 hours at120ûF (49ûC) with power aeration. Consult aerator manufacturer formore specific instructions.

Ceramic ComponentsDo not resterilize ceramic femoral heads.

INFORMATIONFor further information, please contact Customer Service at (800) 238-7538 for cal ls wi th in the cont inental USA and (901) 396-2121 for all international calls.

Authorized EC Representative: Smith & Nephew Orthopaedics GmbH,Tuttlingen, Germany.

Caution: Federal Law (USA) restricts this device to sale by or onthe order of a physician.

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Smith & Nephew, Inc. • 1450 Brooks Road • Memphis, TN 38116 U.S.A.(901) 396-2121 • For information: 1-800-821-5700 • For orders and order inquiries: 1-800-238-7538

www.smithnephew.com/echelon

POROUS / PRIMARY

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