ESSENTIAL PRODUCT INFORMATION S-ROM …

1 DESIGN in USA. 2005 DePuy Orthopaedics, Inc. All rights more INFORMATION about the S-ROM Modular Hip System, visit our web site at PRODUCT INFORMATION S-ROM MODULAR HIP SYSTEMREFERENCES1. Krygier, , Bobyn, , et al. Strength,stability, and wear analysis of a modular titanium femoral hip prosthesis tested infatigue. Orthopaedic Research Laboratory,Montreal General Hospital, Montreal, Christie, , et al. Primary Total HipArthroplasty with Use of the Modular S-ROMP rosthesis. Journal of Bone & Joint Surgery,Dec. 1999: Noble, , et al. The Anatomic Basis ofFemoral Component Design. CORR235,October 1988: Paul, , et al. Development of a SurgicalRobot for Cementless Total Hip Arthroplasty.

2 CORR285, Dec. 1992: 57-66.* Additional sizes are :This ESSENTIAL PRODUCT INFORMATION sheet does not include all of theinformation necessary for selection and use of a device. Please see fulllabeling for all necessary :Total Hip Arthroplasty (THA) is intended to provide increased patientmobility and reduce pain by replacing the damaged hip joint articulation inpatients where there is evidence of sufficient sound bone to seat andsupport the components. The components of the S-ROM Total Hip Systemare indicated for use in total hip replacement procedures for patientssuffering severe pain and disability due to structural damage in the hip jointfrom rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagendisorders, avascular necrosis, and nonunion of femoral fractures.

3 Use of theprosthesis is also indicated for revision of previous hip arthroplasty and forpatients with congenital hip dysplasia, protrusio acetabuli, slipped capitalfemoral epiphysis, and disability due to previous :Use is contraindicated in cases with active or recent joint sepsis,insufficient bone stock, marked atrophy or deformity in the upper femur,skeletal immaturity, or where loss of musculature or neuromusculardisease would render the procedure AND PRECAUTIONS: The following conditions tend to adversely affect hip replacement implants:excessive patient weight, high levels of patient activity, likelihood of falls,poor bone stock, metabolic disorders, disabilities of other femoral heads with +12 neck length extension are contraindicatedfor use with the POLY-DIAL constrained liner.

4 Use of the Alumina ceramic head without the preassembled taper adaptor is ceramic femoral heads are indicated for use only with acetabularshells composed of UHMWPE or metal-backed UHMWPE. The femoralhead size and the inner diameter of the acetabular components mustcorrespond. SPA proximal sleeves are indicated for cemented use , ZT HA, and ZTT oversized proximal sleeves must be used with S-ROMstems having a nominal proximal diameter 2 mm smaller than thenominal diameter of the sleeve. For all other S-ROM proximal sleeves, thenominal proximal stem diameter must correspond with the nominaldiameter of the sleeve. The trochanter screws and washers must be usedtogether with the S-ROM 36+21 calcar replacement neck femoral EVENTS: Peripheral neuropathy, deep wound infection, and heterotopic boneformation have been reported following hip replacements.

5 Subclinicalnerve damage has also been reported. Dislocation, subluxation, muscleand fibrous tissue laxity, and loosening may also ceramic femoral heads are composed of new ceramic materials withlimited clinical histories. Because of the limited clinical and preclinicalexperience, the long-term biological effects of these particulates are Femoral Sleeves*ZTT PorousZT HydroxyapatiteCoated (Sterile)Coated (Sterile)Cat. No. DescriptionCat. No. Description55010414D-LRG550121 16B-SML550103 14D-SML550122 16B-LRG550102 14B-LRG550124 16D-SML550101 14B-SML550125 16D-LRG550506 14F-LRG550127 16F-SML521463 16B-SML550128 16F-LRG521465 16B-LRG550129 16F-XXL550513 16D-SML550145 18B-SML550514 16D-LRG550146 18B-LRG550515 16F-SML550148 18D-SML550516 16F-LRG550149 18D-LRG550520 16F-XXL550151 18F-SML521483 18B-SML550152 18F-LRG521485 18B-LRG550153 18F-XXL550523 18D-SML550109

6 20B-SML550524 18D-LRG550110 20B-LRG550525 18F-SML550112 20D-SML550526 18F-LRG550113 20D-LRG550530 18F-XXL550115 20F-SML521403 20B-SML550116 20F-LRG521405 20B-LRG550117 20F-XXL550533 20D-SML550133 22B-SML550534 20D-LRG550134 22B-LRG550535 20F-SML550136 22D-SML550536 20F-LRG550137 22D-LRG550540 20F-XXL550139 22F-SML521423 22B-SML550140 22F-LRG521425 22B-LRG550141 22F-XXL550543 22D-SML550157 24B-SML550544 22D-LRG550158 24B-LRG550545 22F-SML550160 24D-SML550546 22F-LRG550161 24D-LRG550550 22F-XXL550163 24F-SML550561 24B-SML550164 24F-LRG550562 24B-LRG550165 24F-XXL550564 24D-SML550565 24D-LRG550567 24F-SML550568 24F-LRG550569 24F-XXLM odular Femoral Stem prosthesis *Standard-Length Stems, Standard Necks (Sterile)Cat.

7 Size (mm) Neck Length (mm)DIST x PROX x LENGTH523292 11 x 16 x 15030523192 11 x 16 x 15036523293 13 x 18 x 16030523193 13 x 18 x 16036523393 13 x 18 x 16042523194 15 x 20 x 16536523394 15 x 20 x 16542523195 17 x 22 x 1653652339517 x 22 x 16542523196 19 x 24 x 17536523396 19 x 24 x 17542 Standard-Length Stems, Standard Necksand Lateral Necks (Sterile)Cat. Size (mm)Neck Length (mm)DIST x PROX x LENGTH56351611 x 16 x 15030 + 456351711 x 16 x 15036 + 656351813 x 18 x 16030 + 452341813 x 18 x 16036 + 8523420 15 x 20 x 16536 + 852342217 x 22 x 16536 + 852342419 x 24 x 17536 + 852319313 x 18 x 16036 + 1252319415 x 20 x 16536 + 1252319517 x 22 x 16536 + 12S-ROM Femoral mmCat.

8 No. Neck Length52-2022+028 mmCat. No. Neck Length52-2028+087-5953+352-2029+687-5954 +952-2030+1232 mmCat. No. Neck Length52-2032+087-5955+352-2033+687-5956 +952-2034+1228 mm M HeadsCat. No. Neck Length1365-16-500+01365-17-500+31365-18- 500+636 mm M HeadsCat. No. Neck Length1365-26-000-31365-31-000+01365-32- 000+31365-33-000+61365-34-000+91365-36-0 00+12 BIOLOX delta CeramicFemoral Heads28 mmCat. No. Neck Length1365-28-210+01365-28-220+31365-28- 230+632 mmCat. No. Neck Length1365-32-210+01365-32-220+31365-32- 230+636 mmCat. No. Neck Length1365-36-210+01365-36-220+31365-36- 230+6 M Heads are precision polished for use withUltamet metal inserts or Marathon cross-linked DECADES OF SUCCESSVERSATILITY CHOICES IN THE OPERATING ROOMThe modular S-ROM prosthesis is unique.

9 The independent neck andsleeve can accommodate a proximal-distal mismatch while providingample opportunity for leg length adjustment. The S-ROM stem alsoallows placement of version to maximize range of motion andresulting hip stability. These features combined with the availability of high-offset stems achieve restoration of patient biomechanicswithout negatively affecting leg YEARS OF PROVEN SUCCESSThe S-ROM Modular Hip System has been used successfully for more than 20 yearsin more than 125,000 cases, and its strength and stability have been proven in clinicaland laboratory other modular hip system can boast 98 percentsurvivorship in primary hip other modular hip system can offerup to six neck length/lateral offset options per stem diameter for primary other modular hip system can offer as much intraoperative acetabular systemwith advanced bearing optionsIndependent neck and sleeveenables 360 degrees of versionScore marks help addressstem/sleeve alignmentCoronal slot reduces distalstem stiffness and may helpreduce end-stem thigh painDistal flutes enhance rotational stability Sleeves are available with proprietaryZTT porous and ZT HA coatingsMultiple stem

10 Lengths offer arange of stability options,especially for fractures anddiscontinuitiesLateralized neck options allow offsetadjustment without affecting leg lengthSUCCESSTWO DECADES OF SUCCESSVERSATILITY CHOICES IN THE OPERATING ROOMThe modular S-ROM prosthesis is unique. The independent neck andsleeve can accommodate a proximal-distal mismatch while providingample opportunity for leg length adjustment. The S-ROM stem alsoallows placement of version to maximize range of motion andresulting hip stability. These features combined with the availability of high-offset stems achieve restoration of patient biomechanicswithout negatively affecting leg YEARS OF PROVEN SUCCESSThe S-ROM Modular Hip System has been used successfully for more than 20 yearsin more than 125,000 cases.