BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) COCR NECK

    MDR report key: 4233415 · Received November 6, 2014

    Report

    Report Number
    3010536692-2014-01560
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE NECK WAS BROKEN SUDDENLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713453 PROFEMUR(R) COCR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 1489775

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention