BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 880381 · Received July 12, 2007

    Report

    Report Number
    1226188-2007-00008
    Event Type
    Injury
    Date Received
    July 12, 2007
    Date of Event
    June 5, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBER 220610 APEX MODULAR LONG 50 NECK. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    POROUS FEMORAL STEM REVISED 48 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. DURING REVISION, SURGEON NOTED FAILURE OF THE FEMORAL STEM ALIGNMENT PIN. PT. IN GOOD CONDITION POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC., 5 X 14 STEM 372

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention