BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMP HIP INSTRUMENT

    MDR report key: 1935379 · Received November 17, 2010

    Report

    Report Number
    1644408-2010-00624
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT END OF LIFE - THE SHELL IMPACTOR SCREW IN HANDLE BECAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP INSTRUMENT ACETABULAR POSITIONER LXH ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1