BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION(TM) MP FEMORAL COMPONENT

    MDR report key: 6192821 · Received December 21, 2016

    Report

    Report Number
    3010536692-2016-01541
    Event Type
    Injury
    Date Received
    December 21, 2016
    Report Date
    December 13, 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

    VOID MDR, DUPLICATE INCIDENT AND PART AND INCIDENT REPORTED UNDER 3010536692-2016-01495.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT HAD DEEP WOULD INFECTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844311 EVOLUTION(TM) MP FEMORAL COMPONENT KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention