BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2222559 · Received August 16, 2011

    Report

    Report Number
    1644408-2011-00458
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT FELL CAUSING TRAUMA/TEAR TO MEDICAL COLLATERAL LIGAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE NON-POROUS FEMUR JWH ENCORE MEDICAL, L.P. 53995395

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 385-09-504, LOT 53976886