BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE LEGION FE

    MDR report key: 2800932 · Received October 23, 2012

    Report

    Report Number
    1020279-2012-00570
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    October 18, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STUDY PATIENT: IT WAS REPORTED THA THE PATIENT EXPERIENCED PAIN. THE PATIENT WENT TO A DIFFERENT SURGEON AND HAD THE DEVICES REMOVED AND ANTIBIOTIC SPACERS IMPLANTED. MULTIPLE ATTEMPTS WERE MADE TO GATHER INFORMATION FROM THE PATIENT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE LEGION FE VISIONAIRE KDC SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention