MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah GMRS DIST FEM COMP STD L 65MM; prosthesis, hip, semi-constrained, metal/polymer, cemented

Catalog Number	64952030
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	07/25/2025
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: this pi is for the impending 2025 revision.As per pss implant request case: conversion of stryker left gmrs distal femur & proximal tibia to a fixed hinge.Usage stickers given for initial ((b)(6) 2023) and revision case ((b)(6) 2023) left proximal tibia and distal femoral gmrs in-situ, requires conversion to fixed hinge.Leaving as much of current implant in-situ.Initial implantation of proximal tibia gmrs and distal femoral gmrs completed on (b)(6) 2023 with 10mm tibial insert, revised on (b)(6) 2023 to 16mm tibial insert.A 30mm extension piece was used, unsure on whether this was utilised on femur or tibia, will confirm once imaging is received from surgeon.Update: this revision was booked for patella stabilization.The patient has a chronically subluxing patella due to the rotating hinge component of the prosdasthesis.A prosthesis which limits the rotation rather than eliminating it would be acceptable too.Mi sestimate the patella dislocates when the tibia externally rotates¿ update 25/3/2026: completion of custom proximal tibia replacement and revision.Successful completion of surgery.Surgeon modified mrh axle 64812120 with cemented fibre tape to stabilise patella.Replacement of insitu distal femur, proximal tibia, and bearing components.

• Brand Name: GMRS DIST FEM COMP STD L 65MM
• 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-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24933887
• Report Number: 0002249697-2026-00304
• Device Sequence Number: 17438269
• Product Code: JDI
• UDI-Device Identifier: 07613327049824
• UDI-Public: 07613327049824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 64952030
• Device Lot Number: RRX6R
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• 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: 62 YR
• Patient Sex: Female