BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 4033019 · Received August 25, 2014

    Report

    Report Number
    3010536692-2014-01219
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-01220, -01221. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (LEFT). THE PATIENT DECOMPENSATED RIGHT AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514331 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 039835283

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death