BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 3655330 · Received March 3, 2014

    Report

    Report Number
    3010536692-2014-00331
    Event Type
    Injury
    Date Received
    March 3, 2014
    Date of Event
    October 2, 2013
    Report Date
    February 5, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. EVENT CODE IS ADDRESSED IN PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00330, -003332, -00333. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127422 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 068619019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention