BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 2498502 · Received March 21, 2012

    Report

    Report Number
    3004594167-2012-00004
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    December 12, 2011
    Report Date
    March 12, 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

    DEVICE INFORMATION: TIBIAL BASEPLATE: LOT 1009038-A, CATALOG 100297, MANUFACTURE: 02/2011, EXPIRATION: 02/2013; TIBIAL INSERT: LOT 1009022-A, CATALOG 100326, MANUFACTURE: 02/2011, EXPIRATION: 02/2013. 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

    PATIENT UNDERWENT OPEN FRACTURE REDUCTION AND PLATING FOR A TIBIAL PLATEAU FRACTURE SUBSEQUENT TO UNICOMPARTMENTAL KNEE ARTHROPLASTY. THE IMPLANTS WERE LEFT IN PLACE. REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.

    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, INC. 113002-A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R