BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS SPIKED CUP

    MDR report key: 2605420 · Received June 8, 2012

    Report

    Report Number
    1043534-2012-00521
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    April 9, 2012
    Report Date
    May 7, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K031963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-522.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO HIGH METAL ION LEVELS WITH CLUNKING AND SQUEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS SPIKED CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 066343519

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention