BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS SPIKED CUP

    MDR report key: 3655328 · Received March 3, 2014

    Report

    Report Number
    3010536692-2014-00330
    Event Type
    Injury
    Date Received
    March 3, 2014
    Date of Event
    October 2, 2013
    Report Date
    February 5, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. EVENT CODE IS ADDRESSED IN PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00331, -003332, -00333. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127893 CONSERVE(R) PLUS SPIKED CUP HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 117479940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention