BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 1914460 · Received November 23, 2010

    Report

    Report Number
    1644408-2010-00638
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    MEH
    PMA / PMN Number
    K993943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT FELL IN REHAB AND FRACTURED THE PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP FEMORAL STEM MEH ENCORE MEDICAL, L.P. 53938703

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention (B)(4), LOT: A1000003| (B)(4), LOT: 53911146