MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah MRHK TIB INS 10MM XS/S S1/S2; Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

Catalog Number	64813210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision/exploration of distal femur gmrs r due to pain.Revised distal femur and articulating components- patella added.No issue with devices reported.Notification only.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: device name# gmrs dist fem comp std r 65mm ; cat# 64952040; lot# p437d, device name# mrhk tibial sleeve ; cat# 64812140; lot# lkt583, device name# mrh tib rot comp xs-xl ; cat# 64812100; lot# 186017, device name# mrhk femoral bushing ; cat# 64812110; lot# lkt626, device name# mrh axle ; cat# 64812120; lot# ctd84268, device name# mrhk bumper ins - neutral ; cat# 64812130; lot# llh632, device name# mrhk femoral bushing ; cat# 64812110; lot# lkt626.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: MRHK TIB INS 10MM XS/S S1/S2
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50476269
• Report Number: 0002249697-2026-00783
• Device Sequence Number: 10323527
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 08/27/2026

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: 64813210
• Device Lot Number: LLP244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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: 61 YR
• Patient Sex: Female