BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA SYSTEM

    MDR report key: 4134997 · Received September 25, 2014

    Report

    Report Number
    3004594167-2014-00004
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # K090024 COVERS INITIAL RELEASE OF TGS UKA SYSTEM INCLUDING ALL INSTRUMENTATION, FEMORAL IMPLANTS, AND ALL-POLY TIBIAL IMPLANTS; 510 (K) # K101206 COVERS THE REPLACEMENT OF THE ALL-POLY TIBIAL IMPLANTS WITH TIBIAL BASEPLATE IMPLANTS AND TIBIAL INSERT IMPLANTS. FEMORAL: LOT # 1111001-B; CATALOG # 100415; MFG DATE: 02/2013 EXP DATE: 02/2016. TIBIAL BASEPLATE: LOT # 1202013; CATALOG # 100299; MFG DATE: 02/2013 EXP DATE: 02/2016. TIBIAL INSERT: LOT # 1112006-A; CATALOG # 100335; MFG DATE: 03/2012 EXP DATE: 03/2015. THE TIBIAL INSERT WAS ONLY REPLACED AND WAS NOT RETURNED FOR EVALUATION. THE OTHER TWO COMPONENTS WERE LEFT IN THE PATIENT. THE DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED AND THERE WAS NO EVIDENCE SUGGESTING OF ANY IMPLANT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO RECEIVED TGS (MIRROR) IMPLANTS ON (B)(6) 2014, WAS SUSPECTED TO HAVE AN INFECTION AND WAS SCHEDULED FOR A "WASH OUT" PROCEDURE ON (B)(6) 2014. THE TIBIAL INSERT WAS REPLACED WITH A NEW ONE DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596625 TGS UKA SYSTEM UNICOMPARTMENTAL KNEE ARTHROPLASTY HSX CAYENNE MEDICAL, INC. 1111001-B

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention