BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA

    MDR report key: 2400501 · Received December 29, 2011

    Report

    Report Number
    3004594167-2011-00011
    Event Type
    Injury
    Date Received
    December 29, 2011
    Date of Event
    December 1, 2011
    Report Date
    December 29, 2011
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, INC.
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DEVICES: TIBIAL BASEPLATE: LOT # 1009036-A, CAT # 100295, EXP DATE: (B)(6) 2013, MANUFACTURE DATE: (B)(6) 2011. TIBIAL INSERT: LOT # 1009014-A, CAT # 100316, EXP DATE: (B)(6) 2013, MANUFACTURE DATE: (B)(6) 2011. PRODUCT WAS NOT RETURNED FOR EVAL. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ALEXANDRIA RESEARCH TECHNOLOGIES CONSIDERS THE INVESTIGATION OF THIS EVENT CLOSED AT THIS TIME. SHOULD THE PRODUCT BE RETURNED OR ADD'L INFO RECEIVED, THE INVESTIGATION MAY BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS CONVERTED TO A TOTAL KNEE DUE TO PERSISTENT PAIN. CONVERSION WAS UNEVENTFUL. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MFG TO SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TGS UKA UNICOMPARTMENT KNEE COMPONENT HSX ALEXANDRIA RESEARCH TECHNOLOGIES, INC. 1004012

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R