BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 2460651 · Received February 17, 2012

    Report

    Report Number
    3004594167-2012-00003
    Event Type
    Injury
    Date Received
    February 17, 2012
    Date of Event
    January 10, 2012
    Report Date
    February 9, 2012
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, INC.
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWICE, ADDITIONAL INFO WAS REQUESTED FROM THE DOCTOR AND NOT RECEIVED WITHIN THE 30 DAY WINDOW. THIS REPORT IS BEING FILED WITH THE INFO AVAILABLE TO COMPLY WITH THE 30 DAY REPORTING REQUIREMENT. WHEN ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PT WAS CONVERTED TO A TOTAL KNEE DUE TO ANTERIOR PAIN. CONVERSION WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TGS UKA FEMORAL AND TIBIAL COMPONENTS UNICOMPARTMENTAL KNEE COMPONENT HSX ALEXANDRIA RESEARCH TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R