MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6021-3535
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: a patient who underwent tha (accolade tmzf) on (b)(6) 2012.The neck trunnion of the accolade tmzf wore out, causing the head to dislocate from the stem within the hip joint, necessitating revision arthroplasty on (b)(6) 2025.During the revision surgery, the surgeon observed metallosis of the surrounding tissues associated with stem wear.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding disassociation involving an accolade stem was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.The stem trunnion is severely worn.Clinician review: a review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient underwent a primary right total hip arthroplasty because i was able to see an x-ray with the implant in place.I can also confirm that the patient developed a head neck disassociation on the right side and revision of that implant, also because i was able to see x-rays with the implants in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head neck disassociation with subsequent metallosis is multi factorial including surgical technique, especially in the way that the femoral head and trunnion are prepared prior to and during insertion, patient factors including activity level, lifestyle and bmi and implant factors.Implant positioning can also play a role, especially since this patient has a notch in the trunnion." 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 the patient was revised due to disassociation of the head from the stem.Visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.The stem trunnion is severely worn.A review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient underwent a primary right total hip arthroplasty because i was able to see an x-ray with the implant in place.I can also confirm that the patient developed a head neck disassociation on the right side and revision of that implant, also because i was able to see x-rays with the implants in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head neck disassociation with subsequent metallosis is multi factorial including surgical technique, especially in the way that the femoral head and trunnion are prepared prior to and during insertion, patient factors including activity level, lifestyle and bmi and implant factors.Implant positioning can also play a role, especially since this patient has a notch in the trunnion." 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 (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23533806
• Report Number: 0002249697-2025-01316
• Device Sequence Number: 9021446
• Product Code: JDI
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 06/30/2017
• Device Catalogue Number: 6021-3535
• Device Lot Number: 39983101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 73 KG