BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUROUS FEMORAL K2 TAPERED STEM

    MDR report key: 1061562 · Received June 17, 2008

    Report

    Report Number
    1226188-2008-00015
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 16, 2008
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K041950
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOTAL HIP PERFORMED 2008. SMALL GAP BETWEEN STEM AND NECK OBSERVED ON X-RAY POST OPERATIVELY. SURGEON PERFORMED REVISION ABOUT TWO MONTHS LATER, AND REPLACED THE NECK. THE NECK SEATED PROPERLY AND THE STEM STAYED SOLIDLY IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POUROUS FEMORAL K2 TAPERED STEM POROUS FEMORAL NECK KWY OMNI LIFE SCIENCE, INC. NECK, MEDIUM 47.5 1564

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention