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	Unspecified Infection (1930)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: gmrs dist fem comp sml l 65mm; cat# 64952010; lot# lnt2y, mrh tibial b/plt keel med 2; cat# 64813112; lot# l6h2t, triathlon cemented stem-15mm x 50mm; cat# 5560-s-115; lot# 0116696d, gmrs connection piece 90mm lft; cat# 64956009; lot# ctd33854, gmrs small axle; cat# 64952115; lot# ctd62983, gmrs small femoral bushing; cat# 64952105; lot# ljh404, mrhk tibial sleeve; cat# 64812140; lot# lkp085, mrhk bumper insert 3 degrees; cat# 64812133; lot# lkx420, mrh tib rot comp xs-xl; cat# 64812100; lot# 180633a, gmrs extension piece 180mm; cat# 64956180; lot# na47p, gmrs small femoral bushing; cat# 64952105; lot# unknown.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: the patient had an index left tka outside of cors scope.Patient had multiple pjis and revisions outside cors scope.On (b)(6) 2022.Patient underwent revision for pji with total femur.(at this time gets included into cors).The patient developed pji again and was revised on (b)(6) 2024.All components were exchanged.But with off-label use components.

• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 23836080
• Report Number: 0002249697-2025-01493
• Device Sequence Number: 5094083
• Product Code: KRO
• UDI-Device Identifier: 07613327043846
• UDI-Public: 07613327043846
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 64813313
• Device Lot Number: LKP935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2021
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 73 KG