BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TGS UKA FEMORAL - 50MM

    MDR report key: 3733087 · Received March 27, 2014

    Report

    Report Number
    3004594167-2014-00002
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 26, 2014
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HSX
    PMA / PMN Number
    K090024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR EVAL. THERE WAS NO EVIDENCE SUGGESTING ANY PRODUCT/ SYSTEM FAILURE, AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE MFR WAS INFORMED THAT A PT WITH A TGS UKA IMPLANT HAD BEEN SEEN ARTHROSCOPICALLY DUE TO PERSISTENT PAIN. THE PT UNDERWENT A REVISION ON (B)(6) 2014 TO CONVERT TO A TOTAL KNEE ARTHROPLASTY (TKA). UPON CONVERSATION WITH THE SURGEON ABOUT THE CASE, IT WAS FOUND THAT THE FEMORAL IMPLANT WAS LOOSE AT THE TIME OF CONVERSION. THE RESULTS OF INVESTIGATION CONCLUDED THAT THERE IS NO EVIDENCE REASONABLY SUGGESTING THAT THE TGS FEMORAL IMPLANT WAS THE CAUSE FOR THE CONVERSION TO A TOTAL KNEE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179927 TGS UKA FEMORAL - 50MM UNICOMPARTMENTAL KNEE ARTHROPLASTY HSX CAYENNE MEDICAL, INC. 0911004

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R