BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 2103684 · Received May 26, 2011

    Report

    Report Number
    3004594167-2011-00005
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 18, 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

    ADDITIONAL CATALOG NUMBER: T 100011; ADDITIONAL LOT NUMBER: T 090402; ADDITIONAL EXPIRATION DATE: 11/01/2009. (B)(6) 2009. 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 INFO RECEIVED, THE INVESTIGATION MAY BE RE-OPENED.

    Description of Event or Problem · 1

    SURGEON INDICATED THAT A TGS UKA PT PRESENTED IN CLINIC WITH LEFT KNEE PROGRESSING IN VARUS. PT WAS SUBSEQUENTLY CONVERTED TO A TOTAL KNEE. THE PROCEDURE 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. F 0911004

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R