BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RAZ STEM

    MDR report key: 3594867 · Received January 28, 2014

    Report

    Report Number
    3010536692-2014-00075
    Event Type
    Injury
    Date Received
    January 28, 2014
    Date of Event
    January 9, 2013
    Report Date
    January 13, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. EVENT CODE IS ADDRESSED IN PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00072, -00073, -00074. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60701 PROFEMUR(R) RAZ STEM HIP COMPONENT, CODE:LPH LPH MICROPORT ORTHOPEDICS INC. 036284376

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention