MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-0537

Device Problems Corroded (1131); Degraded (1153); Disassembly (1168)

Patient Problems Injury (2348); Osteolysis (2377); Reaction (2414)

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.

• Brand Name: ACCOLADE TMZF HIP STEM #5
• Type of Device: PROSTHESIS, 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 Key: 7620182
• MDR Text Key: 111706491
• Report Number: 0002249697-2018-01897
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (Y/N): N
• Reporter Country Code: CA
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 06/20/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 07/31/2014
• Device Catalogue Number: 6020-0537
• Device LOT Number: 30057604
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/09/2009
• 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