BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3980009 · Received August 5, 2014

    Report

    Report Number
    3010536692-2014-01021
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE MODULAR NECK WAS BROKEN DURING WALKING ON DRY ASPHALT. UNABLE TO REMOVE THE NECK. THE STEM WAS REMOVED. THE STEM OF S&N WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457680 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. 0711382687

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention