MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM M/L M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813310
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: cat#; device name; lot#: 64812130; mrhk bumper insert - neutral; unknown 64952105; gmrs small femoral bushing; unknown 64812140; mrhk tibial sleeve; unknown 64952020; gmrs dist fem comp sml r 65mm; unknown 64812100; mrh tib rot comp xs-xl; unknown 64952115; gmrs small axle; unknown 64952105; gmrs small femoral bushing; 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: it was reported that upon revision, polyethylene wear was observed on the tibial sleeve, tibial insert, bumper.Rotating component, distal femur.Patient revised due to right knee instability.Patient revised with new, analagous components.

• Brand Name: MRHK TIB INS 10MM 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: 25314903
• Report Number: 0002249697-2026-00473
• Device Sequence Number: 15984689
• Product Code: KRO
• UDI-Device Identifier: 07613327043822
• UDI-Public: 07613327043822
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K223069
• 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): 05/28/2026

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: 64813310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male
• Patient Weight: 91 KG