BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 2211401 · Received August 8, 2011

    Report

    Report Number
    3004594167-2011-00002
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    March 9, 2011
    Report Date
    August 5, 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

    EXPIRATION DATE(S): FEMORAL, EXP. UNK. TIBIAL, CATALOG#, LOT#, EXP. UNK. THIS REPORT IS LATE SINCE WE WERE WAITING FOR MORE INFO FROM THE DOCTOR AND NEVER RECEIVED IT. 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

    IN A PHONE CONVERSATION WITH ON (B)(6) 2011, DOCTOR INDICATED THAT A TGS UKA PT SEEN BY HIS PARTNER "OVER CHRISTMAS" PRESENTED WITH AN INFECTED KNEE. X-RAYS SHOWED CHANGES IN SUPPORTING BONE AT THAT TIME AND HIS PARTNER OPENED AND RINSED THE KNEE, BUT LEFT THE IMPLANTS IN PLACE. ON (B)(6) 2011, THE PARTNER CONVERTED THE TGS UKA TO A TOTAL KNEE BECAUSE OF TIBIAL COMPONENT LOOSENING. THE PROCEDURE WENT UNEVENTFULLY.

    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 FEMORAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R