BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 1981204 · Received January 26, 2011

    Report

    Report Number
    1644408-2011-00047
    Event Type
    Other
    Date Received
    January 26, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD AN EXACTECH ACETABULAR SHELL AND LINER. IN ADDITION, THE PATIENT HAD A DJO SURGICAL LIMA STEM AND FEMORAL HEAD. THE PATIENT DISLOCATED, AS A RESULT, A CONSTRAINED EXACTLY LINER WAS IMPLANTED AND A NEW DJO R 8MM NEUTRAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP COCR HEAD NEUTRAL KWA ENCORE MEDICAL, L.P. 53854989

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention