BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NECK

    MDR report key: 6133125 · Received November 29, 2016

    Report

    Report Number
    3010536692-2016-01464
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2014
    Report Date
    November 2, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 HIP PROTHESIS FRACTURE (RIGHT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782920 NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention