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

Model Number	6020-0537
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Insufficient Information (4580)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported through claimant's counsel that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2011 and was revised on (b)(6) 2022.During the revision the surgeon noted "¿ there was a significant amount of black metallosis fluid encountered.An extensive debridement of all metal debris was performed and it was found that his trunnion was completely destroyed.".
Event or Problem Description
It was reported through claimant's counsel that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2011 and was revised on (b)(6) 2022.During the revision the surgeon noted "¿ there was a significant amount of black metallosis fluid encountered.An extensive debridement of all metal debris was performed and it was found that his trunnion was completely destroyed.".
Additional Manufacturer Narrative
Reported event: an event regarding wear involving an accolade stem that was mated with an lfit v40 cocr head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: a review of the device history records indicates the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot.Conclusion: the reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE TMZF HIP STEM #5
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15046515
• Report Number: 0002249697-2022-01027
• Device Sequence Number: 5646469
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 6020-0537
• Device Catalogue Number: 6020-0537
• Device Lot Number: 34732206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male