BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) TL STEM

    MDR report key: 2991707 · Received March 6, 2013

    Report

    Report Number
    1043534-2013-00466
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    March 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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 1043534-2013-00465, 00467. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED. THE PRODUCT WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96100 PROFEMUR(R) TL STEM HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention