BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK BUMPER INSERT - NEUTRAL

    MDR report key: 25213629 · Received May 19, 2026

    Report

    Report Number
    0002249697-2026-00406
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 19, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327045260
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MRS CVD FEM ST W/O BODY 15X127; CAT#: 64853815; LOT#: 267844A. GMRS EXTENSION PIECE 30MM; CAT#: 64956030; LOT#: 762PU. MRHK FEMORAL BUSHING; CAT # 64812110; LOT # LRA010. GMRS DIST FEM COMP STD L 65MM; CAT#: 64952030; LOT#: 6R22R. MRH AXLE; CAT#: 64812120; LOT#: CTD97336. MRH TIB ROT COMP XS-XL; CAT#: 64812100; LOT#: 230951. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF FEMUR DISTAL FEMUR GMRS AND TOTAL HIP REPLACEMENT (NOT STRYKER PRODUCTS) INSITU. NO REPORTED ISSUE WITH STRYKER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465423 MRHK BUMPER INSERT - NEUTRAL PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LNX434 07613327045260

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R