BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 2093719 · Received April 21, 2011

    Report

    Report Number
    1644408-2011-00218
    Event Type
    Other
    Date Received
    April 21, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 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 - DUE TO OSTEOLYSIS BEHIND THE ACETABULAR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP HEMI W/HOLES SHELL LPH ENCORE MEDICAL, L.P. 770521

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 432-28-010, LOT 4222271