MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	6021-4535
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	04/01/2026
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 has been similar event(s) 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: the hip gives way, resulting in a fall during an everyday activity; an x-ray subsequently reveals a conical fracture of the femoral shaft.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation, crack/fracture and metallosis involving an accolade stem was reported.Disassociation and metallosis were confirmed via medical review.Crack/fracture was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary left total hip arthroplasty since i was able to review an x-ray with the implant in place.I can only confirm revision by the fact that it was mentioned on the product inquiry summary and there was a translation of a revision procedure supplied without any date or identification.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head neck disassociation with metallosis are multifactorial including surgical technique, especially in the way the femoral head and trunnion are prepared prior to insertion, patient factors including activity level, lifestyle, and bmi, as well as implant factors".Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to conical fracture of the femoral shaft.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary left total hip arthroplasty since i was able to review an x-ray with the implant in place.I can only confirm revision by the fact that it was mentioned on the product inquiry summary and there was a translation of a revision procedure supplied without any date or identification.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head neck disassociation with metallosis are multifactorial including surgical technique, especially in the way the femoral head and trunnion are prepared prior to insertion, patient factors including activity level, lifestyle, and bmi, as well as implant factors".No further investigation for this event is possible at this time.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: ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; +353()61498200
• MDR Report Key: 25091282
• Report Number: 0002249697-2026-00374
• Device Sequence Number: 21329802
• Product Code: JDI
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 6021-4535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 145 LB