BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 3802220 · Received May 9, 2014

    Report

    Report Number
    3010536692-2014-00769
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    December 10, 2007
    Report Date
    May 1, 2014
    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

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-00767, 00768.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO BONE FRACTURE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D 4/21/2015: PT. EXPERIENCED PAIN AND MOBILITY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280305 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 067444091

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention