MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 9 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0937
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	11/04/2025
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
Patient revised due to a biolox 36 head +7.5 fracture.(left side) surgeon took out stem and broken head and revised to restoration modular component and new liner.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving an accolade stem was reported.The event was confirmed.Method & results: product evaluation and results: the device was not returned; however, a photograph was provided for review.The photograph shows a recently explanted ceramic head, a stem and a liner.The stem trunnion appears worn out.Clinician review: a review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a primary total hip arthroplasty and sustained a fracture of the ceramic femoral head since i was able to see a radiograph of the hip and photographs of the explanted prostheses.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of ceramic femoral head fracture are multifactorial, including possible surgical technique with unrecognized damage to the femoral head upon insertion, patient factors, including activity level, lifestyle, and bmi, as well as the possibility of trauma and implant factors." 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 fractured ceramic head.The device was not returned; however, a photograph was provided for review.The photograph shows a recently explanted ceramic head, a stem and a liner.The stem trunnion appears worn out.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a primary total hip arthroplasty and sustained a fracture of the ceramic femoral head since i was able to see a radiograph of the hip and photographs of the explanted prostheses.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of ceramic femoral head fracture are multifactorial, including possible surgical technique with unrecognized damage to the femoral head upon insertion, patient factors, including activity level, lifestyle, and bmi, as well as the possibility of trauma and implant factors." if devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: SIZE 9 ACCOLADE II 127 DEG
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 23657484
• Report Number: 0002249697-2025-01386
• Device Sequence Number: 13292924
• Product Code: LPH
• UDI-Device Identifier: 04546540669544
• UDI-Public: 04546540669544
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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 Catalogue Number: 6721-0937
• Device Lot Number: 97453004
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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: 53 YR
• Patient Sex: Male