BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION(TM) MP CS INSERT

    MDR report key: 6150755 · Received December 7, 2016

    Report

    Report Number
    3010536692-2016-01496
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 04/03/2018. UPDATED THE REVISION DATE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804006 EVOLUTION(TM) MP CS INSERT HIP COMPONENT HRY MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention