BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 763242 · Received September 19, 2006

    Report

    Report Number
    1226188-2006-00009
    Event Type
    Injury
    Date Received
    September 19, 2006
    Date of Event
    August 30, 2006
    Report Date
    September 18, 2006
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBER 200410 MEDIUM 47.5 NECK, CATALOG NUMBER 332800 28MM+0 ALUMINA HEAD. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    TOTAL HIP ARTHROPLASTY REVISED 49 MONTHS AFTER PRIMARY HIP REPLACEMENT SURGERY. AT REVISION, COBALT CHROME ALIGNMENT PIN IN THE STEM WAS OBSERVED TO HAVE SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. 5X13 STEM 151

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization