BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) COCR NECK

    MDR report key: 6072966 · Received November 2, 2016

    Report

    Report Number
    3010536692-2016-01333
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    July 30, 2016
    Report Date
    October 4, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT IS BEING REVISED DUE TO A MODULAR NECK BREAK. POSSIBLY CORROSION VISIBLE ON THE NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723031 PROFEMUR(R) COCR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 1201259485

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention