BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) SUPER FINISH FEMORAL

    MDR report key: 4241823 · Received November 10, 2014

    Report

    Report Number
    3010536692-2014-01589
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    July 24, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-01588. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS (LEFT). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723385 CONSERVE(R) SUPER FINISH FEMORAL HIP COMPONENT KXA MICROPORT ORTHOPEDICS INC. 0949164710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention