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	Unspecified Infection (1930)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had an index left tka (outside of cors scope).The patient developed mechanical instability, and was revised on (b)(6) 2022.(made it into cors).All components exchanged.Patient develops mechanical complication and pain and was revised on (b)(6) 2025.Only poly and rotating components were exchanged.
Additional Manufacturer Narrative
The following devices were also listed in this report: mrh axle; cat # 64812120; lot # ctd62963.Mrhk femoral bushing; cat # 64812110; lot # lkp060.Mrhk femoral bushing; cat # 64812110; lot # lkn226.Mrhk tibial sleeve; cat # 64812140; lot # lkr257.Mrhk bumper ins 3degrees; cat # 64812133; lot # llb186.Mrh tib rot comp xs-xl; cat # 64812100; lot # 18067.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50422111
• Report Number: 0002249697-2026-00749
• Device Sequence Number: 15747494
• Product Code: KRO
• UDI-Device Identifier: 07613327043785
• UDI-Public: 07613327043785
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 09/30/2026
• Device Catalogue Number: 64813210
• Device Lot Number: LKY671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2021
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 155 LB