BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 2870965 · Received December 12, 2012

    Report

    Report Number
    1043534-2012-01654
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 15, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01653, 01655. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED. THE PRODUCT WAS DIMENSIONALLY INSPECTED AND PHOTOGRAPHIC IMAGES WERE MADE OF THE PRODUCT. (B)(4): MEETS SPECIFICATION.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 058608776

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention