BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 2990295 · Received March 5, 2013

    Report

    Report Number
    1043534-2013-00433
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 21, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01419, 1043534-2013-00434.THIS EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY LEFT HIP WAS REVISED DUE TO MOM COMPLICATIONS. ORIG. SURG. (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93113 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 049849873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention