BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 789074 · Received November 27, 2006

    Report

    Report Number
    1226188-2006-00014
    Event Type
    Injury
    Date Received
    November 27, 2006
    Date of Event
    November 21, 2006
    Report Date
    November 27, 2006
    Manufacturer
    OMNI LIFE SCIENCE, INC
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBER 200310 SHORT+47.5 NECK. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    POROUS FEMORAL STEM REVISED 53 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. AT REVISION SURGERY, COBALT CHROME ALIGNMENT PIN IN THE FEMORAL 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 4X13 STEM 150

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention