BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) SF CEMENTED FEMORAL COMPONENT

    MDR report key: 4192838 · Received October 22, 2014

    Report

    Report Number
    3010536692-2014-01517
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT REVISED DUE TO SHEDDING OF METAL DEBRIS INTO BLOODSTREAM; TISSUE DAMAGE; PERSISTENT PAIN AND DECREASED MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673135 CONSERVE(R) SF CEMENTED FEMORAL COMPONENT HIP JOINT COMPONENT KXA MICROPORT ORTHOPEDICS INC. 017399276

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention