BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA SYSTEM

    MDR report key: 3670047 · Received February 12, 2014

    Report

    Report Number
    3004594167-2014-00001
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    November 25, 2013
    Report Date
    February 11, 2014
    Manufacturer
    CAYENNE MEDICAL, INC
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. # K101206 COVERS THE REPLACEMENT OF THE ALL-POLY TIBIAL IMPLANTS WITH TIBIAL BASEPLATE IMPLANTS AND TIBIAL INSERT IMPLANTS. FEMORAL: LOT # 1004013; CATALOG # 100280; MFG DATE: 12/2010; EXP. DATE: 12/2012. TIBIAL BASEPLATE: LOT # 1009037-A; CATALOG # 100296; MFG DATE: 02/2011; EXP. DATE: 02/2013; TIBIAL INSERT: LOT # 1103033-A; CATALOG # 100322; MFG DATE 06/2011; EXP. DATE 06/2013. PRODUCT WAS NOT RETURNED FOR EVALUATION. THERE WAS NO EVIDENCE SUGGESTING ANY PRODUCT/SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    DURING A PHONE CONVERSATION WITH THE SURGEON ON (B)(6) 2014, THE MANUFACTURER WAS INFORMED THAT A PATIENT WITH A TGS UKA IMPLANT HAD BEEN SEEN FOR PERSISTENT PAIN AND THE IMPLANT WAS CONVERTED TO A TOTAL KNEE ARTHROPLASTY (TKA). UPON CONVERSATION WITH THE SURGEON ABOUT THE CASE, IT WAS FOUND THAT THE FEMORAL IMPLANT WAS LOOSE DUE TO THE PATIENT'S OSTEOPOROTIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92645 TGS UKA SYSTEM UNICOMPARTMENTAL KNEE ARTHROPLASTY HSX CAYENNE MEDICAL, INC 1004013

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R