MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0435
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
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 reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that a patient with an accolade tmzf required a revision surgery due to a damaged trunnion.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding disassociation involving an accolade stem was reported.The event was confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photograph shows a recently explanted stem and head.From the photographs provided there is evidence of wear of the trunnion of the stem which would be consistent with taper lock failure.There are markings, distally on the stem, most likely from the explanation process.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the x-ray image shows a dissociation of a femoral head from the femoral stem.The trunnion is deformed with significant material loss of the superior aspect.Dissociation of a femoral head from a femoral stem with trunnion deformation is confirmed.Product history review: review of the device history records indicate the 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: the reported device was not returned however photographs were provided for review.The photograph shows a recently explanted stem and head.From the photographs provided there is evidence of wear of the trunnion of the stem which would be consistent with taper lock failure.There are markings, distally on the stem, most likely from the explanation process.A review of the provided medical records by a clinical consultant stated the following comment: the x-ray image shows a dissociation of a femoral head from the femoral stem.The trunnion is deformed with significant material loss of the superior aspect.Dissociation of a femoral head from a femoral stem with trunnion deformation is confirmed.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22858567
• Report Number: 0002249697-2025-00898
• Device Sequence Number: 13101215
• Product Code: LPH
• UDI-Device Identifier: 04546540510693
• UDI-Public: 04546540510693
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 07/31/2018
• Device Catalogue Number: 6021-0435
• Device Lot Number: 44152901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2013
• 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 Sex: Unknown