BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMP HIP

    MDR report key: 2102874 · Received May 3, 2011

    Report

    Report Number
    1644408-2011-00257
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE TWO CENTRAL SCREWS SNAPPED OUT OF THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP NON-HOODED HEMI MULTI-HOLE TRIAL LINER LPH ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 803-52-441, LOT UNKNOWN