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)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: trunion fracture.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding fracture, wear & disassociation involving an accolade stem was reported.The events for wear & disassociation were confirmed via medical review.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: "the x-rays demonstrate dissociation of the femoral head from the stem.There is extensive remodeling of the trunnion with significant material loss on the superior aspect of the trunnion.No trunnion fracture is identified.Dissociation of the femoral head from the stem with extensive remodeling of the trunnion and significant material loss on the superior aspect of the trunnion is confirmed.The root cause of this mechanical complication is not able to be determined from the limited information provided.Should further documentation become available i would be happy to further this investigation." 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 trunnion facture.A review of the provided medical records by a clinical consultant indicated: "the x-rays demonstrate dissociation of the femoral head from the stem.There is extensive remodeling of the trunnion with significant material loss on the superior aspect of the trunnion.No trunnion fracture is identified.Dissociation of the femoral head from the stem with extensive remodeling of the trunnion and significant material loss on the superior aspect of the trunnion is confirmed.The root cause of this mechanical complication is not able to be determined from the limited information provided.Should further documentation become available i would be happy to further this investigation." 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.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23137221
• Report Number: 0002249697-2025-01023
• Device Sequence Number: 21054899
• Product Code: JDI
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 6021-4535
• Device Lot Number: UNKNOWN
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/28/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 116 KG