BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION HIP INSTRUMENT

    MDR report key: 1950305 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00657
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE T-HANDLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP INSTRUMENT FEMORAL T-HANDLE LXH ENCORE MEDICAL, L.P. 38178L06

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR