BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINOS AXIOM TOTAL ANKLE REPLACEMENT SYSTEM

    MDR report key: 20206173 · Received September 12, 2024

    Report

    Report Number
    3014833750-2024-00001
    Event Type
    Injury
    Date Received
    September 12, 2024
    Report Date
    September 12, 2024
    Manufacturer
    RESTOR3D, INC.
    Product Code
    HSN
    UDI-DI
    00850022178122
    PMA / PMN Number
    K192778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - CLINICAL CODE (E): CLINICAL CODE 2646 "INADEQUATE OSSEOINTEGRATION" CHOSEN AS IT WAS THE CLOSEST TO THE INTENDED CODE OF 4883 "ASEPTIC LOOSENING". INTENDED CODE WAS NOT RECOGNIZED BY THE SYSTEM THUS ALTERNATIVE CODE WAS SELECTED. AS PART OF THE INVESTIGATION, IMAGES OF THE PATIENT'S ANKLE AT THE TIME OF THE ORIGINAL SURGERY AND NOW WERE REVIEWED FOR POTENTIAL CAUSE FOR THE REPORTED TIBIAL IMPLANT LOOSENING. IN THE IMAGES, IT APPEARS THAT BONE CEMENT WAS NOT USED ON THE BONE CONTACTING SURFACE OF THE IMPLANT, ALTHOUGH THE DEVICE IS ONLY INDICATED FOR USE WITH CEMENT, PER LBL-50013 IFU -KINOS TAR. BONE CEMENT IS USED TO SECURELY AFFIX THE IMPLANT TO THE BONE; WITHOUT IT, THERE IS POTENTIAL RISK OF IMPLANT LOOSENING, AS SEEN REPORTED IN THE COMPLAINT. BASED ON THE INVESTIGATION, THE ARE NO DEFICIENCIES WITH THE DESIGN OR RISK CONSIDERATIONS OF THE IMPLANT OR THE ABILITY OF THE PLASMA SPRAY/BONE CEMENT COMBINATION TO PROVIDE SECURE FIXATION TO THE DISTAL TIBIA.

    Description of Event or Problem · 0

    TIBIAL IMPLANT LOOSENING ON A TOTAL ANKLE REPLACEMENT WHICH IS 3 YEARS OLD REQUIRING REVISION OF THE TIBIAL IMPLANT. THE LOOSENING RECENTLY APPEARED AND OTHER THAN THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475319 KINOS AXIOM TOTAL ANKLE REPLACEMENT SYSTEM TOTAL ANKLE HSN RESTOR3D, INC. 1801-2140 2008023 00850022178122

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention