BEUDAMED
    FDA Adverse Event Other Summary report: N

    TGS UKA TIBIAL INSERT

    MDR report key: 2651984 · Received July 3, 2012

    Report

    Report Number
    3004594167-2012-00006
    Event Type
    Other
    Date Received
    July 3, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 6, 2012
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, INC.
    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

    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

    THE PT WAS TAKEN TO THE OPERATING ROOM FOR TREATMENT OF INFECTION. THE PT HAD AN ACUTE POST-OPERATIVE INFECTION WITH PURULENT DRAINAGE. THE PT WAS TAKEN TO OPERATING ROOM FOR A SUPERFICIAL AND DEEP I&D. THE POLYETHYLENE WAS CHANGED AS USUALLY MODULAR PARTS ARE EXCHANGED AT THE TIME OF INFECTION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TGS UKA TIBIAL INSERT UNICOMPARTMENTAL KNEE COMPONENT HSX ALEXANDRIA RESEARCH TECHNOLOGIES, INC. 1103037-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention