BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMORAL HEAD COMPONENTS

    MDR report key: 1080992 · Received July 23, 2008

    Report

    Report Number
    1644408-2008-00222
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT COMPLAINING OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL HEAD COMPONENTS ALUMINA CERAMIC HEAD KWY ENCORE MEDICAL, L.P. 248102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention