MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 13MM M/L M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user has reported that an unexpected issue was observed with operated knee 29 days after a gmrs surgery performed on (b)(6) 2025.At this time, the cause of the incident has not yet been determined.The surgeon has advised that the patient will undergo a revision procedure to directly assess the situation and determine the underlying causes.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: 61931010; simplexhv ce genta 10 pack; 434ba983jf.64813112; mrh tibial b/plt keel med 2; tje4p.64812100; mrh tib rot comp xs-xl; 205586a2.64952030; gmrs dist fem comp std l 65mm; tdd6j.6495-5-215; 15mm press fit bowed stem 150; 247223b.64786625; ti dur reg fluted stem 15x80mm;125982.64812120; mrh axle ctd;121107.64812150; mrh hdp assembly pack; llm089.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 13MM M/L M2/L2
• 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: 23022445
• Report Number: 0002249697-2025-00972
• Device Sequence Number: 21218966
• Product Code: KRO
• UDI-Device Identifier: 07613327043846
• UDI-Public: 07613327043846
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 64813313
• Device Lot Number: LLB725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male