BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY(R) A-CLASS(R) POLY LINER

    MDR report key: 2142505 · Received June 28, 2011

    Report

    Report Number
    1043534-2011-00297
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K070785
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS NOT RETURNED.(B)(4).

    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 1043534-2011-00298, 00299, 00300, AND 00301.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED FOR LINER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNASTY(R) A-CLASS(R) POLY LINER HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 068590319

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R