BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) FEMORAL RESURFACING HEAD

    MDR report key: 2874382 · Received December 14, 2012

    Report

    Report Number
    1043534-2012-01682
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    September 28, 2011
    Report Date
    November 15, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KXA
    PMA / PMN Number
    K944752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED FOR RECURRENT INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) FEMORAL RESURFACING HEAD HIP COMPONENT, CODE:KXA KXA WRIGHT MEDICAL TECHNOLOGY, INC. 050A120359

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention