BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 2174962 · Received July 21, 2011

    Report

    Report Number
    3004594167-2011-00009
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    April 18, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG #: 100026. ADD'L LOT #: 0904008. ADD'L EXPIRATION DATE: 05/2011. ADD'L DEVICE MANUFACTURE DATE: 05/2009. PRODUCT WAS NOT RETURNED FOR EVAL. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DOCTOR PERFORMING THE CONVERSION: (B)(6). ALEXANDRIA RESEARCH TECHNOLOGIES CONSIDERS THE INVESTIGATION OF THIS EVENT CLOSED AT THIS TIME. SHOULD THE PRODUCT BE RETURNED OR ADD'L INFO REC'D, THE INVESTIGATION MAY BE RE-OPENED.

    Description of Event or Problem · 1

    SURGEON INDICATED THAT ONE OF HIS PTS SENT HIM A NOTE INDICATING THE PT WAS CONVERTED TO A TOTAL KNEE BY ANOTHER SURGEON IN ROANOKE VA FOR A LOOSE TIBIAL COMPONENT. CONVERSION TO TOTAL KNEE 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, LLC 0902008

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R