BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2214074 · Received July 19, 2011

    Report

    Report Number
    1644408-2011-00409
    Event Type
    Other
    Date Received
    July 19, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT IS DISLOCATING. ORIGINALLY SHE HAD A UNIPOLAR, THEN CONVERTED TO A TOTAL, TIGHT ANTERIOR CAPSULE, THE SURGEON REPLACED A SIZE 46MM SHELL WITH A SIZE 48MM SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP HEMISPHERICAL SHELL W/SCREWHOLES LPH ENCORE MEDICAL, L.P. 53937798

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention