MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0335
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Broken trunnion on tmzf stem.Revised femoral stem and replaced acetabular liner.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem was reported.The event was confirmed via clinical review of provided medical records.Method & results: -product evaluation and results: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted head, stem and liner.The trunnion of the stem has penciled.The head is unidentifiable and the photograph does not show the head in its entirety.-clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation of event: i can confirm that the patient underwent a total hip arthroplasty that sustained a head neck disassociation since i was able to view the xray.I can also confirm that clinical findings were consistent with metallosis since i was able to see an intraoperative x-ray showing soft tissue metallosis.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head neck disassociation, trunnionosis and metallosis are multifactorial including initial surgical technique, especially in the way that the femoral head and trunnion are prepared prior to insertion, patient factors including activity level, lifestyle and bmi, and implant factors.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that 'broken trunnion on tmzf stem.Revised femoral stem and replaced acetabular liner.' a review of the provided medical records by a clinical consultant indicated: confirmation of event: i can confirm that the patient underwent a total hip arthroplasty that sustained a head neck disassociation since i was able to view the xray.I can also confirm that clinical findings were consistent with metallosis since i was able to see an intraoperative x-ray showing soft tissue metallosis.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head neck disassociation, trunnionosis and metallosis are multifactorial including initial surgical technique, especially in the way that the femoral head and trunnion are prepared prior to insertion, patient factors including activity level, lifestyle and bmi, and implant factors.The exact cause of the event could not be determined because insufficient information was provided.Further information such as the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible 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 #3
• 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: 23587116
• Report Number: 0002249697-2025-01341
• Device Sequence Number: 9397945
• Product Code: LPH
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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 Catalogue Number: 6020-0335
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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