BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) COCR NECK

    MDR report key: 6075409 · Received November 3, 2016

    Report

    Report Number
    3010536692-2016-01346
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    October 4, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO: PAINFUL TRUNNIONOSIS AND HIGH COBALT LEVELS IN BLOODSTREAM. (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726158 PROFEMUR(R) COCR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 1537311

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention