BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) FEMORAL COMPONENT

    MDR report key: 2922466 · Received January 18, 2013

    Report

    Report Number
    1043534-2013-00066
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 27, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. 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. PHOTOGRAPHIC IMAGES WERE MADE.(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY RESURFACING HEAD WAS RETURNED. UNKNOWN FAILURE. ORIG. SURG. AND REV. DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28071 CONSERVE(R) FEMORAL COMPONENT HIP JOINT COMPONENT, CODE:KXA KXA WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention