BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 2072172 · Received April 28, 2011

    Report

    Report Number
    1043534-2011-00169
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00170.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND. DEVICE HISTORY RECORD REVIEWED. PRODUCT NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED, UNDETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO SUSPECTED METAL SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS CUP HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 078595159

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R