MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6721-0737
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: a fracture was confirmed at the distal end of the stem during the post-operative x-ray.Two wires were used for it.The physician commented that it must have cracked when put in the trial or the implant.
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
No new information.
Additional Manufacturer Narrative
Reported event an event regarding intraop fracture involving an accolade stem was reported.The event was confirmed via clinician review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.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 right total hip arthroplasty and a periprosthetic fracture since i was able to view an x-ray showing the clinical situation.Root cause analysis: the root cause of this event can be determined with certainty.The cause is iatrogenic.Preparation broaching or insertion of the implant could lead to fracture especially if the implant chosen was larger than the patient's bone envelope.If there was a small breach of the cortex on broaching, insertion could expand this.Undue force on insertion can also cause fracture.In this case i did not see any significant osteopenia which could also contribute.I would not assign any causality to the patient or the implant itself." 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 a fracture was confirmed at the distal end of the stem during the post-operative x-ray.Two wires were used for it.The physician commented that it must have cracked when put in the trial or the implant.A review of the provided medical records by a clinical consultant indicated that the event can be confirmed."the root cause of this event can be determined with certainty.The cause is iatrogenic.Preparation broaching or insertion of the implant could lead to fracture especially if the implant chosen was larger than the patient's bone envelope.If there was a small breach of the cortex on broaching, insertion could expand this.Undue force on insertion can also cause fracture.In this case i did not see any significant osteopenia which could also contribute.I would not assign any causality to the patient or the implant itself." if further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: SIZE 7 ACCOLADE II 127 DEG
• 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: 23788974
• Report Number: 0002249697-2025-01461
• Device Sequence Number: 14845547
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250989
• 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): 05/22/2026

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: 6721-0737
• Device Lot Number: 18877051A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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 Sex: Unknown