MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah MRHK BUMPER INSERT - NEUTRAL; prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

Catalog Number	64812130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mrs cvd fem st w/o body 15x127; cat#: 64853815; lot#: 267844a.Gmrs extension piece 30mm; cat#: 64956030; lot#: 762pu.Mrhk femoral bushing; cat # 64812110; lot # lra010.Gmrs dist fem comp std l 65mm; cat#: 64952030; lot#: 6r22r.Mrh axle; cat#: 64812120; lot#: ctd97336.Mrh tib rot comp xs-xl; cat#: 64812100; lot#: 230951.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: revision of femur distal femur gmrs and total hip replacement (not stryker products) insitu.No reported issue with stryker devices.

• Brand Name: MRHK BUMPER INSERT - NEUTRAL
• 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 ; +1(201)831-5000
• MDR Report Key: 25213629
• Report Number: 0002249697-2026-00406
• Device Sequence Number: 18750309
• Product Code: KRO
• UDI-Device Identifier: 07613327045260
• UDI-Public: 07613327045260
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 64812130
• Device Lot Number: LNX434
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male