BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP METAL-ON-METAL

    MDR report key: 1230266 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00400
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K040354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    STEM WAS LOOSE AND DOCTOR WANTED TO CHANGE THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP METAL-ON-METAL LINER KWA ENCORE MEDICAL, L.P. 53882655

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention LOT# 53880857| LOT# 53796548| LOT# 53879414