BEUDAMED
    FDA Adverse Event Other Summary report: N

    CERAMIC FEMORAL HEAD

    MDR report key: 1242524 · Received November 21, 2008

    Report

    Report Number
    1038671-2008-00066
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 21, 2008
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG DEVICE HISTORY RECORD INDICATES THE DEVICE WAS MANUFACTURED TO SPEC. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A TOTAL HIP ARTHROPLASTY (THA) WAS REVISED APPROX 8 YEARS POST OPERATIVELY DUE TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMIC FEMORAL HEAD FEMORAL HEAD KWY EXACTECH, INC. C-28M

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R