BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION

    MDR report key: 1230284 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00417
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K935449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUP HAD MOVED AND WAS WORN INDICATING IT HAD BEEN OUT OF PLACE FOR SOME TIME. THE SURGEON REPLACED THE CUP AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION COCR FEMORAL HEAD KWY ENCORE MEDICAL, L.P. 671151

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention