BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 774038 · Received October 24, 2006

    Report

    Report Number
    1226188-2006-00013
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    September 21, 2006
    Report Date
    October 24, 2006
    Manufacturer
    OMN LIFE SCIENCE INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: CATALOG NUMBERS 121456 6X14.5 APEX MODULAR STEM, 332800 ALUMINA 28MM MEDIUM HEAD. DEVICE HISTORY RECORDS FOR THE MODULAR STEM AND NECK ARE INTACT AND CONFORMING AND INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT FELL AND FRACTURED HIP STEM, 44 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. AT REVISION SURGERY IN 2006, MODULAR NECK WAS FRACTURED AT THE LATERAL PEG, WHERE THE NECK JOINS THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMN LIFE SCIENCE INC. MEDIUM 47.5 NECK 277

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization