BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) SUPER FINISH FEMORAL

    MDR report key: 2991717 · Received March 6, 2013

    Report

    Report Number
    1043534-2013-00489
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    November 17, 2011
    Report Date
    October 22, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    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 1043534-2013-00488. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94922 CONSERVE(R) SUPER FINISH FEMORAL HIP COMPONENT, CODE:KXA KXA WRIGHT MEDICAL TECHNOLOGY, INC. 037411952

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention