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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6020-0537
Device Problems Corroded; Degraded; Disassembly
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative

Conclusion: cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision. Additionally, there is osteolysis around the proximal stem section although the stem remains well fixed in the more distal parts. Also around the cup is osteolysis evident, especially around the supplemental screw fixation although also the cup still appears stable in the bone near the periphery. Not returned.

 
Event Description

It was reported that on (b)(6) 2018, dr. (b)(6) performed a revision of an accolade stem with a dislocated femoral head component as visible by preop x-ray. Update per med review: cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision. Additionally, there is osteolysis around the proximal stem section although the stem remains well fixed in the more distal parts. Also around the cup is osteolysis evident, especially around the supplemental screw fixation although also the cup still appears stable in the bone near the periphery.

 
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Brand NameACCOLADE TMZF HIP STEM #5
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
brian lauro
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7620182
Report Number0002249697-2018-01897
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2014
Device Catalogue Number6020-0537
Device LOT Number30057604
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/09/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/20/2018 Patient Sequence Number: 1
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