BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 2946003 · Received February 6, 2013

    Report

    Report Number
    1043534-2013-00215
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    May 1, 2012
    Report Date
    January 2, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(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. THIS IS THE SAME EVENT AS 1043534-2013-00214, 00216, 00217.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS. LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50314 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 078608785

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention