BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM M/L M2/L2

    MDR report key: 24203380 · Received January 28, 2026

    Report

    Report Number
    0002249697-2026-00060
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 28, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043846
    PMA / PMN Number
    K223069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MRHK BUMPER INSERT - NEUTRAL; CAT # 64812130; LOT # LKR798, MRHK FEMORAL BUSHING; CAT # 64812110; LOT # LKH501, MRHK FEMORAL BUSHING; CAT # 64812110; LOT # LKL452, MRH AXLE; CAT # 64812120; LOT # CTD50587, MRH TIB ROT COMP XS-XL; CAT # 64812100; LOT # 177810A, MRHK TIBIAL SLEEVE; CAT # 64812140; LOT # LKM483, TI DUR REG FLUTED STEM13X155MM; CAT # 64786695; LOT # 0052412, MRH KNEE FEM L RGT; CAT # 64811131; LOT # HHC6R, TI DUR REG FLUTED STEM12X155MM; CAT #64786690; LOT # 0107420, DURACON L-2 10MM FULL WEDGE; CAT #6630-6-535; LOT # DHS3UA, MRH TIBIAL B/PLT KEEL LRG 2; CAT # 64813113; LOT # LS29P, 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.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. ALL COMPONENTS EXCEPT THE BASEPLATE, FEMORAL COMPONENT, WEDGE AND STEMS WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265627 MRHK TIB INS 13MM M/L M2/L2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LHN654 07613327043846

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R