BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION(TM) MP CS INSERT

    MDR report key: 3013410 · Received March 20, 2013

    Report

    Report Number
    1043534-2013-00569
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 18, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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.(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.

    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. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT COMPLAINT OF NOT FEELING RIGHT. SURGEON PERFORMED A POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116035 EVOLUTION(TM) MP CS INSERT KNEE COMPONENT, CODE:JWH JWH WRIGHT MEDICAL TECHNOLOGY, INC. 0211313505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention