BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMP HIP INSTRUMENT

    MDR report key: 2091144 · Received May 10, 2011

    Report

    Report Number
    1644408-2011-00262
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    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 HANDLE (T-HANDLE ALIGNER) FALLS OFF WHEN THE SURGEON IMPACTS THE SHELL INTO THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP INSTRUMENT ACETABULAR POSITIONER LXH ENCORE MEDICAL, L.P. 50592101

    Patients

    Seq Age Sex Outcome Treatment
    1