BEUDAMED
    FDA Adverse Event Other Summary report: N

    MTS KNEE

    MDR report key: 1912762 · Received November 2, 2010

    Report

    Report Number
    1644408-2010-00581
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K905613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS EXPERIENCING PAIN. THE SURGEON DECIDED TO PERFORM AN IND AND LINER EXCHANGE AND MAKE SURE THERE WAS NO INFECTION. REMOVED OLD LINER AND IMPLANTED A NEW ONE, OLD IMPLANT WAS IN PERFECT SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS KNEE TIBIAL INSERTS JWH ENCORE MEDICAL, L.P. 216571

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention