MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah SIZE 3 ACCOLADE II 127 DEG; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	6721-0330
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: reported by the doctor: patient s.H.Underwent hip arthroplasty with the mako robot - on (b)(6) 2026 with the placement of the accolade ii stem.After a few days in a post-operative consultation, it was noticed that there was sinking of the stem.

• Brand Name: SIZE 3 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24936296
• Report Number: 0002249697-2026-00309
• Device Sequence Number: 10671380
• Product Code: JDI
• UDI-Device Identifier: 04546540669483
• UDI-Public: 04546540669483
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6721-0330
• Device Lot Number: 27216251A
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Female