BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 5098114 · Received September 23, 2015

    Report

    Report Number
    3010536692-2015-01782
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    June 4, 2013
    Report Date
    September 23, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2015-01781.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: PAIN; ELEVATED COBALT LEVELS; IMPAIRED GAIT AND MOBILITY; AND EVIDENCE OF METALLOSIS WITH LOOSENING OF THE ACETABULAR COMPONENT WITH BLOOD TINGED AND CLEAR SYNOVIAL FLUID: RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628011 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 046338149

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention