BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE HIP INSTRUMENTATION

    MDR report key: 1111824 · Received August 14, 2008

    Report

    Report Number
    1644408-2008-00257
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IMPACTOR HEAD BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE HIP INSTRUMENTATION FEMORAL STEM IMPACTOR HWA ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention