BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) TL STEM

    MDR report key: 2873964 · Received December 14, 2012

    Report

    Report Number
    1043534-2012-01676
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    May 16, 2012
    Report Date
    November 13, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PRODUCT WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    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 1043534-2012-01672, 01673, 01674, 01675.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD MOM COMPLICATIONS REQUIRING REVISION. LEFT HIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention