BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS DIST FEM COMP STD L 65MM

    MDR report key: 22683198 · Received July 31, 2025

    Report

    Report Number
    0002249697-2025-00777
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    April 21, 2014
    Report Date
    July 31, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327049824
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING OF FEMORAL COMPONENT. FEMORAL COMPONENT REVISED. LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155220 GMRS DIST FEM COMP STD L 65MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327049824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R