BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE COCR FEMORAL HEAD COMPONENT

    MDR report key: 1220526 · Received October 29, 2008

    Report

    Report Number
    1644408-2008-00379
    Event Type
    Other
    Date Received
    October 29, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K973302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - REPEATED DISLOCATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE COCR FEMORAL HEAD COMPONENT HEAD, M-M FEM. 28/NEU KWY ENCORE MEDICAL, L.P. 53943950

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention 436-28-005