MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-5537
Medical Device Problem Codes	Material Erosion (1214); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Product not returned.
Event or Problem Description
It was reported, through the filing of a lawsuit, that the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip and was later revised.It is alleged that he suffered injuries as a result of implantation and explantation of the device, device recall, and excessive levels of cobalt and chromium in his blood.
Additional Manufacturer Narrative
Reported event: an event regarding wear/metallosis and altr/abnormal ion level involving an accolade stem that was mated with an lfit v40 cocr head was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the revision operative report dated (b)(6) 2020 (b)(4) described gross trunnionosis with significant material loss of the trunnion.The surgeon notes in his report that there was gross metallosis throughout the hip.It is confirmed that an lfit v40 metal head was implanted on an accolade stem in 2007.This tha was revised (b)(6) 2018.The root cause of this mechanical failure cannot be determined from the documentation provided." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to elevated ion levels, altr, and severe trunnion wear generating metallic debris.The reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of 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.
Event or Problem Description
It was reported, through the filing of a lawsuit, that the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip and was later revised.It is alleged that he suffered injuries as a result of implantation and explantation of the device, device recall, and excessive levels of cobalt and chromium in his blood.Update per medical records received 21-nov-2023,"radiographs demonstrated an oblique femoral head on the femoral stem.This radiographic finding is indicative of an impending gross trunnion failure.When the hip was dislocated, the femoral head was removed and there was gross visible damage to the trunnion where approximately (b)(4) of the trunnion had been worn away along the approximate top half of the mortise taper.Again, to emphasize, there was gross visible wear of the trunnion on the stem after the head was removed.".

• Brand Name: ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8135188
• Report Number: 0002249697-2018-03915
• Device Sequence Number: 13871196
• Product Code: LPH
• UDI-Device Identifier: 04546540510778
• UDI-Public: 04546540510778
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024
• 2 Devices were Involved in the Event: 1 2

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: 12/31/2011
• Device Catalogue Number: 6021-5537
• Device Lot Number: 20677401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2006
• 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: 72 YR
• Patient Sex: Male