BEUDAMED
    FDA Adverse Event Summary report: N

    DYNASTY(R) COCR LINER

    MDR report key: 5529611 · Received March 28, 2016

    Report

    Report Number
    3010536692-2016-00411
    Date Received
    March 28, 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

    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
    186167 DYNASTY(R) COCR LINER HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 129998770

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention