BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP

    MDR report key: 2181457 · Received July 5, 2011

    Report

    Report Number
    1644408-2011-00378
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KIH
    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 CEMENT RESTRICTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP CEMENT PLUG INSERTER KIH ENCORE MEDICAL, L.P. A1025268

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR