BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 3211696 · Received July 8, 2013

    Report

    Report Number
    1043534-2013-01118
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    August 13, 2012
    Report Date
    February 20, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    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. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043435-2013-01119, 1120, 01121.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD PERSISTENT WORSENING PAIN IN THE RIGHT HIP. SHE HAD NOTICEABLE LIMB LENGTH DISCREPANCY. SHE WAS FOUND TO HAVE ELEVATED METAL ION LEVELS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309505 CONSERVE(R) PLUS CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 088669022

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention