BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA SYSTEM

    MDR report key: 3022805 · Received March 22, 2013

    Report

    Report Number
    3004594167-2013-00004
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, INC
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) #K090024 COVERS INITIAL RELEASE OF TGS UKA SYSTEM INCLUDING ALL INSTRUMENTATION, FEMORAL COMPONENTS, AND ALL-POLY TIBIAL COMPONENTS. 510(K) #K101206 COVERS THE REPLACEMENT OF THE ALL-POLY TIBIAL COMPONENTS WITH TIBIAL BASEPLATE COMPONENTS AND TIBIAL INSERT COMPONENTS. TIBIAL BASEPLATE: LOT #1103020-A, CATALOG #100297, MFG DATE: 06/2011, EXP DATE: 06/2013. TIBIAL INSERT: LOT #1103035-A, CATALOG #100325, MFG DATE: 11/2011, EXP DATE: 11/2013. PRODUCT WAS NOT RETURNED FOR EVAL. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PT PRESENTED WITH PERSISTENT PAIN. CONVERTED TO A TOTAL KNEE ARTHROPLASTY (TKA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119680 TGS UKA SYSTEM UNICOMPARTMENTAL KNEE ARTHROPLASTY HSX ALEXANDRIA RESEARCH TECHNOLOGIES, INC 1103005-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R