BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 1359408 · Received April 9, 2009

    Report

    Report Number
    1226188-2009-00001
    Event Type
    Injury
    Date Received
    April 9, 2009
    Date of Event
    March 7, 2009
    Report Date
    April 7, 2009
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING ROUTERS TO ASSURE THE FEMORAL HEAD WAS WITHIN SPECIFICATIONS. THE BIPOLAR CUP IS AN ORTHO DEVELOPMENT PRODUCT DISTRIBUTED BY OMNI LIFE SCIENCE. THE FEMORAL HEAD WAS AN OMNI PRODUCT.

    Description of Event or Problem · 1

    SURGEON PERFORMED A HIP REPLACEMENT WITH A BIPOLAR CUP. DURING "RANGE OF MOTION", THE SURGEON FELT THAT THE CONSTRUCT WAS NOT STABLE AND CHANGED TO A THR. AFTER THE SURGERY, THE PIVOT BIPOLAR WAS EXAMINED, AND IT WAS OBSERVED THAT THE 28MM FEMORAL HEAD DID NOT MOVE FREELY WITHIN THE BIPOLAR INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL HEAD FEMORAL HEAD KWY OMNI LIFE SCIENCE, INC. 28MM X +10.5 2078

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Hospitalization| R