BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA SYSTEM

    MDR report key: 2897955 · Received January 2, 2013

    Report

    Report Number
    3004594167-2012-00010
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFORMATION - FEMORAL: LOT 0911003, CATALOG: #100280, MFG. DATE: 04/2010, EXP. DATE: 04/2012. PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 ADDITIONAL INFORMATION RECEIVED, THE INVESTIGATION MAY BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH TIBIAL COLLAPSE. CONVERTED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658 TGS UKA SYSTEM UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) HSX ALEXANDRIA RESEARCH TECHNOLOGIES, INC. 0904005

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R