BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY(R) COCR LINER

    MDR report key: 2042614 · Received April 6, 2011

    Report

    Report Number
    1043534-2011-00118
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 1, 2009
    Report Date
    March 4, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K0061844
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS COMPONENT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00117, 00119.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND. DEVICE HISTORY RECORD REVIEWED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNASTY(R) COCR LINER HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 127504543

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R