MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIB SML; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64953101
Medical Device Problem Codes	Degraded (1153); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that "small gmrs femoral component experienced polyethylene wear failure of the bumper axle bushings.Some wear was observed on the small gmrs femoral component and the small gmrs rotating component.Fretting corrosion was observed on the trunnion and taper of the 40mm gmrs extension piece linking the small gmrs proximal tibia and kotz to gmrs adaptor.The extension piece was easy to remove from the adaptor but extremely difficult to remove from the proximal tibia.Blackened flakes observed at tibial trunions." patient presented with instability of the knee 15 years after the components were implanted.
Additional Manufacturer Narrative
An event regarding instability/wear involving a gmrs tibial component was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported devices were not returned; however photographs were provided for review.The photographs show the femoral, tibial, and rotating components after explantation.The poly bearing components appear fractured and/or worn.There is no damage observed on this gmrs tibial component (6495-3-101) in the images provided.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to instability and wear of various components.The reported devices were not returned; however photographs were provided for review.The photographs show the femoral, tibial, and rotating components after explantation.The poly bearing components appear fractured and/or worn.There is no damage observed on this gmrs tibial component (6495-3-101) in the images provided.Further information such as return of the devices, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: GMRS PROXIMAL TIB SML
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23334677
• Report Number: 0002249697-2025-01132
• Device Sequence Number: 16105199
• Product Code: KRO
• UDI-Device Identifier: 07613327048919
• UDI-Public: 07613327048919
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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 Expiration Date: 02/28/2014
• Device Catalogue Number: 64953101
• Device Lot Number: JC4502U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2009
• 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: 52 YR
• Patient Sex: Male