BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION

    MDR report key: 1230271 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00393
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSA
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT'S FEMUR WAS LOOSE AND "HOT" IN BONE SCAN. FEMUR SHOWED SIGNS OF OSTEOLYSIS, ALREADY THE RESULT OF BONE CEMENT AS INSERT AND PATELLA SHOWED LITTLE SIGNS OF WEAR. REPLACED WITH REVISION KNEE, PATELLA WAS NOT EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION FEMUR HSA ENCORE MEDICAL, L.P. 447161

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 322-01-106, LOT# 406381| 350-09-206, LOT# 452091