BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP SYSTEM

    MDR report key: 880382 · Received July 12, 2007

    Report

    Report Number
    1226188-2007-00007
    Event Type
    Injury
    Date Received
    July 12, 2007
    Date of Event
    June 26, 2007
    Report Date
    July 11, 2007
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBER 200410 APEX MODULAR MEDIUM 47.5 NECK.

    Description of Event or Problem · 1

    ALIGNMENT PIN IN THE STEM SHEARED. STEM AND NECK WERE OTHERWISE INTACT. REVISION SURGERY PERFORMED, STEM AND NECK REPLACED WITH APEX/OMNI PRODUCT. PT. STATUS IS GOOD POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP SYSTEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. 5X14.5 STEM/ STEM 268

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention