BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 803690 · Received January 9, 2007

    Report

    Report Number
    1226188-2007-00001
    Event Type
    Injury
    Date Received
    January 9, 2007
    Date of Event
    January 5, 2007
    Report Date
    January 9, 2007
    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 200410 MEDIUM 47.5 NECK. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND CONFORMING, AND INDICATE MFR TO SPEC.

    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 5X13 STEM 142

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention