BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) XM STEM

    MDR report key: 3346207 · Received September 12, 2013

    Report

    Report Number
    1043534-2013-01527
    Event Type
    Injury
    Date Received
    September 12, 2013
    Date of Event
    January 16, 2013
    Report Date
    August 20, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043537-2013-01524, 01525, 01526.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS. LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459699 PROFEMUR(R) XM STEM HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. W05335836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention