BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVELATION HIP

    MDR report key: 1881715 · Received October 6, 2010

    Report

    Report Number
    1644408-2010-00528
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    PMA / PMN Number
    K902264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - WHEN INSTRUMENT WAS RETURNED TO TRAY FOR STERILIZATION, INSTRUMENT BROKE/SEPARATED. COULD HAVE OCCURRED DURING IMPACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1