BEUDAMED
    FDA Adverse Event Other Summary report: N

    3D KNEE

    MDR report key: 1914358 · Received November 17, 2010

    Report

    Report Number
    1644408-2010-00618
    Event Type
    Other
    Date Received
    November 17, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO LIGAMENT LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3D KNEE NON POROUS FEMUR JWH ENCORE MEDICAL, L.P. 53919220

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 392-11-604, LOT 53936295| 120-01-029, LOT 53935557| 324-01-102, LOT 53930837