MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0635
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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 by the customer that "during a tha accolade case today, we encountered an issue with a size 6, 132 offset stem.The implant appeared to sit approximately 4mm higher than the trial.Following implantation, the femur fractured¿though it¿s unclear if this was directly related.We opened a second size 6, 132 offset stem, which fit line-to-line with the trial".
Additional Manufacturer Narrative
Reported event an event regarding size/fit issue & intraoperative fracture involving an accolade stem was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection: visual inspection of the returned device had nothing remarkable to report.Dimensional inspection: the device is dimensionally within specification as per inspection completed.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Material analysis: not performed as this event does not relate to material integrity.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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: it was reported by the customer that "during a tha accolade case today with doctor, we encountered an issue with a size 6, 132 offset stem.The implant appeared to sit approximately 4mm higher than the trial.Following implantation, the femur fractured¿though it¿s unclear if this was directly related.We opened a second size 6, 132 offset stem, which fit line-to-line with the trial".The device is dimensionally within specification as per inspection completed.The exact cause of the event could not be determined.If further information becomes available this investigation will be re-opened.
Event or Problem Description
No new information.

• Brand Name: SIZE 6 ACCOLADE II 132 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21922039
• Report Number: 0002249697-2025-00446
• Device Sequence Number: 18399791
• Product Code: LPH
• UDI-Device Identifier: 04546540664495
• UDI-Public: 04546540664495
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Catalogue Number: 6720-0635
• Device Lot Number: 26238951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 07/12/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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: Other
• Patient Age: 43 YR
• Patient Sex: Male