BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 2222593 · Received August 16, 2011

    Report

    Report Number
    1644408-2011-00467
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE JOINT LOCATOR IN THE KNEE WAS LOOSE, THE SURGEON IMPLANTED A LARGER SIZE TO TIGHTEN IT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE DCM INSERT, 13MM JWH ENCORE MEDICAL, L.P. 53979823

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention