BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD

    MDR report key: 7593884 · Received June 12, 2018

    Report

    Report Number
    3010536692-2018-00797
    Event Type
    Injury
    Date Received
    June 12, 2018
    Report Date
    June 12, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY, PER ARTICLE BY DOWDING AND BEAULE, ET AL., J ARTHROP. 2018: A PATIENT SUFFERED FAILURE BECAUSE OF OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432998 HEAD HIP IMPLANT JDL MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention