BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP SYSTEM

    MDR report key: 1040648 · Received May 7, 2008

    Report

    Report Number
    1644408-2008-00158
    Event Type
    Other
    Date Received
    May 7, 2008
    Date of Event
    January 19, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE IMPLANTING AN FMP ACETABULAR CUP, THE CUP WAS FIXED USING TWO 25MM SCREWS. WHEN TRYING TO TIGHTEN THE SCREWS FIRMLY, THE FIRST SCREW PASSED THROUGH THE HOLE AND REMOVED THE FMP FROM ITS POSITION. SURGEON REMOVED THE SCREWS AND CUP AND, USING THE SAME SCREWS, PUT IT IN AGAIN IN 180 DEGREE ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP SYSTEM CANCELLOUS BONE SCREW. 25MM JDI ENCORE MEDICAL, L.P. 53881467A

    Patients

    Seq Age Sex Outcome Treatment
    1 430-03-044/670461D