BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP LINER

    MDR report key: 1880495 · Received October 13, 2010

    Report

    Report Number
    1644408-2010-00533
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY -THE LINER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP LINER NEUTRAL LINER LPH ENCORE MEDICAL, L.P. 422041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention