BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 5520408 · Received March 23, 2016

    Report

    Report Number
    3010536692-2016-00410
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    July 6, 2015
    Report Date
    March 23, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2016-00411.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT IS SUFFERING FROM MOM COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED 03/08/2016. ALLEGEDLY, THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: METABOLIC MYOPATHY; ELEVATED CPK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175963 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 0101019955

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention