BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS KNEE INNOVATIONS

    MDR report key: 2875245 · Received December 13, 2012

    Report

    Report Number
    3004594167-2012-00009
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 12, 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

    ADD'L INFO: FEMORAL: LOT 0909042, CATALOG #100290, MFG DATE: 10/2009, EXP DATE: 10/2011. 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 PRESENTED WITH TIBIAL COLLAPSE. CONVERTED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TGS KNEE INNOVATIONS UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) HSX ALEXANDRIA RESEARCH TECHNOLOGIES, INC 0910052

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R