BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP SYSTEM

    MDR report key: 906982 · Received August 28, 2007

    Report

    Report Number
    1644408-2007-00149
    Event Type
    Other
    Date Received
    August 28, 2007
    Date of Event
    July 30, 2007
    Report Date
    August 28, 2007
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K955563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON DID NOT LIKE FIT OF CUP ALIGNMENT, SO DECIDED TO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP SYSTEM FEMORAL HEAD KWY ENCORE MEDICAL, L.P. 247282

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization