BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX HIP SYSTEM BIPOLAR HEAD

    MDR report key: 1484091 · Received July 15, 2009

    Report

    Report Number
    1226188-2009-00009
    Event Type
    Malfunction
    Date Received
    July 15, 2009
    Date of Event
    June 18, 2009
    Report Date
    July 14, 2009
    Manufacturer
    OMNI LIFE SCIENCE INC.
    Product Code
    KWY
    PMA / PMN Number
    K082468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS ONGOING AT THE TIME OF THIS FILING.

    Description of Event or Problem · 1

    SIZE 46 BIPOLAR HEAD IMPLANTED. DURING THE RANGE OF MOTION CHECK, THE HEAD OF THE FEMORAL STEM AND THE BIPOLAR ACETABULAR COMPONENT DISLOCATED. A SIZE 45 AND 49 BIPOLAR WERE TRIALED AND EXHIBITED THE SAME PROBLEM. SURGEON SUCCESSFULLY USED A COMPETITORS BIPOLAR PRODUCT. THERE WAS MORE THAN A 10 MINUTE DELAY IN SURGERY. IT WAS STATED THAT THE PT WAS FINE POST SURGERY. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX HIP SYSTEM BIPOLAR HEAD HEMI-HIP PROSTHESIS, UNCEMENTED KWY OMNI LIFE SCIENCE INC. 46MM 5149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention