BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE FEMORAL COMPONENT

    MDR report key: 299745 · Received October 12, 2000

    Report

    Report Number
    1644408-2000-00004
    Event Type
    Injury
    Date Received
    October 12, 2000
    Date of Event
    March 1, 2000
    Report Date
    October 1, 2000
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED BY GERMAN DISTRIBUTOR, REVISION "TKR" 4 YEARS POST-OP AND AFTER TRAUMA EVENT WAS SUCCESSFUL. FEMORAL CONDYLE AT POSTERIOR CHAMBER FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE FEMORAL COMPONENT FEMORAL COMPONENT JWH ENCORE ORTHOPEDICS, INC. * 175391

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention