MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah GMRS EXTENSION PIECE 80MM; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	64956080
Medical Device Problem Codes	Degraded (1153); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	05/26/2026
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 primary procedure of gmrs was done in 2004.Revision surgery was carried out on (b)(6) 2026 due to suspected tibial loosening.However, when dr kc wong open the joint capsule, massive and extensive metallosis was seen around the prosthesis.When we try to impact a new 80mm extension piece, we found that the male taper was much larger than the female taper of the ext.Piece.We struggled that if we need to remove the in-situ stem since we had no idea why the taper looked different.Somehow a nursing staff suggested that part of the female taper of the in-situ 80mm ext.Piece might be peeled off and coldwelded to the stem's male taper.Therefore the surgeons tried to use metal cutting device to cut a bit on the taper.Finally we managed to take away the peeled off part and exposed the original male taper of the stem but it extended the surgery for almost 3/4 hours.Conclusion is that extension piece might have a failure trunnion.

• Brand Name: GMRS EXTENSION PIECE 80MM
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; +353()61498200
• MDR Report Key: 25610317
• Report Number: 0002249697-2026-00526
• Device Sequence Number: 21310871
• Product Code: JDI
• UDI-Device Identifier: 07613327049220
• UDI-Public: 07613327049220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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 Expiration Date: 03/30/2009
• Device Catalogue Number: 64956080
• Device Lot Number: LXAEX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2004
• 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: Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male