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

Catalog Number	6021-0335
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there is an upcoming total hip revision due to dislocation of femoral head from the stem.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem was reported.The event was confirmed via device inspection.Method & results: product evaluation and results: visual inspection of the returned device indicated that the trunnion of the stem is severely worn.The metal head appears to have minor damage from the disassociation event and explantation.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that 'it was reported that there is an upcoming total hip revision due to dislocation of femoral head from the stem.' visual inspection of the returned device indicated that the trunnion of the stem is severely worn.The metal head appears to have minor damage from the disassociation event and explantation.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.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
No new information.

• Brand Name: ACCOLADE PLUS 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: 23353826
• Report Number: 0002249697-2025-01156
• Device Sequence Number: 18424679
• Product Code: LPH
• UDI-Device Identifier: 04546540510686
• UDI-Public: 04546540510686
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 11/30/2015
• Device Catalogue Number: 6021-0335
• Device Lot Number: 34987704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2010
• 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 Sex: Unknown