BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2222597 · Received August 16, 2011

    Report

    Report Number
    1644408-2011-00464
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY, THE PT WAS DISLOCATING, THE CUP WAS POSITIONED INCORRECTLY. A BIGGER HEAD AND OFFSET SLEEVE/LINER WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP FLARED RIM SHELL W/SCREWHOLES LPH ENCORE MEDICAL, L.P. 249122

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 400-32-000, LOT 265072