BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA KNEE SYSTEM

    MDR report key: 2925089 · Received January 17, 2013

    Report

    Report Number
    3004594167-2013-00002
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
    Product Code
    HSX
    PMA / PMN Number
    K0900024
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TIBIAL BASEPLATE: LOT 1009037-A, CATALOG #100296, MFG. DATE: 02/2011, EXP. DATE: 02/2013. TIBIAL INSERT: LOT 1103031-A, CATALOG #100320, MFG. DATE: 11/2011, EXP. DATE: 11/2013. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO EVIDENCE SUGGESTING OF ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. (B)(4) 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

    PT PRESENTED WITH PERSISTENT PAIN. CONVERTED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26238 TGS UKA KNEE SYSTEM UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) HSX ALEXANDRIA RESEARCH TECHNOLOGIES, LLC 1103006-A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R