BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 2055617 · Received April 1, 2011

    Report

    Report Number
    3004594167-2011-00001
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 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 100020; ADDITIONAL LOT NUMBER: T 0904005; ADDITIONAL EXPIRATION DATE: 05/01/2011. MFG DATE: 05/01/2009. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. (B)(6) 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

    IN A PHONE CONVERSATION (B)(6) 2011, DOCTOR INDICATED THAT A TGS UKA PT (B)(6) WAS CONVERTED FROM A TGS UKA TO A TOTAL KNEE THAT MORNING. THE PROCEDURE WENT UNEVENTFULLY. HE INDICATED THIS WAS DUE TO A LOOSE FEMORAL COMPONENT. THE INITIAL SURGERY WAS ON (B)(6) 2010.

    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 0910025

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R