BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RAZ STEM

    MDR report key: 3167225 · Received June 13, 2013

    Report

    Report Number
    1043534-2013-00988
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    October 25, 2012
    Report Date
    May 8, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).

    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 1043534-2013-00985, 00986, 00987.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268051 PROFEMUR(R) RAZ STEM HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 067423523

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention