BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 5026472 · Received August 24, 2015

    Report

    Report Number
    3010536692-2015-01601
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    November 7, 2013
    Report Date
    August 24, 2015
    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

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2015-01600, -01602, -01603.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT REVISED DUE TO PAIN EVIDENCE OF WEAR SOFT TISSUE REACTION AND ELEVATED COCR LEVELS MOM COMPLICATIONS RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559241 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 085256574

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention