BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA KNEE SYSTEM

    MDR report key: 3104614 · Received May 6, 2013

    Report

    Report Number
    3004594167-2013-00005
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, INC.
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 AT THIS TIME. ADDITIONAL INFORMATION: 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 COMPONENT. ADDITIONAL DEVICE INFORMATION: TIBIAL BASEPLATE: LOT: 1103019-A, CATALOG #: 100296, MFG. DATE: 06/2011; EXP. DATE: 06/2011. TIBIAL INSERT: LOT: 1103031-A, CATALOG #: 100320, MFG. DATE: 11/2011; EXP. DATE: 11/2013.

    Description of Event or Problem · 1

    PT PRESENTED WITH PROGRESSION OF ARTHRITIS AND POSSIBLE LOOSENING OF FEMORAL COMPONENT. REVISION SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197309 TGS UKA KNEE SYSTEM UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) HSX ALEXANDRIA RESEARCH TECHNOLOGIES, INC. 1105014-A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R