BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2111183 · Received May 26, 2011

    Report

    Report Number
    1644408-2011-00290
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K953510
    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 AND FRACTURED HER FEMUR ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP MODULAR BIPOLAR SHELL LPH ENCORE MEDICAL, L.P. 53957170

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 400-01-221, LOT 53946680| 425-01-009, LOT 53995450