BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) TAPERED HIP STEM

    MDR report key: 3923652 · Received July 9, 2014

    Report

    Report Number
    3010536692-2014-00983
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 15, 2011
    Report Date
    June 12, 2014
    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

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00981, -00982. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO CONSTANT PAIN AND THE CUP SLIDING OUT OF PLACE (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400546 PROFEMUR(R) TAPERED HIP STEM HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 0747422801

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention