BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2011816 · Received February 24, 2011

    Report

    Report Number
    1644408-2011-00097
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO CHRONIC DISLOCATION AND PT BEING NON-COMPLIANT. THERE IS A POSSIBLE CONTRIBUTION OF SPINE FISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP FEMORAL COCR MONOBLOCK METAL HEAD KWA ENCORE MEDICAL, L.P. 53999892

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention (B)(4), LOT 53924095| (B)(4), LOT A1000008