BEUDAMED
    FDA Adverse Event Other Summary report: N

    3DKNEE

    MDR report key: 1230267 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00399
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    PMA / PMN Number
    K020114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT FELL AND TORE HER LEFT PATELLA LIGAMENT, CHANGING STRESSES IN THE KNEE. SURGEON SAW THERE WAS WEAR ON THE IMPLANT ALSO, SO HE EXPLANTED THE ORIGINAL INSERT, FIXED THE LIGAMENT, TRAILED AND IMPLANTED A NEW 3D INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3DKNEE TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 465252

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention