BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINOS TOTAL ANKLE SYSTEM

    MDR report key: 22729079 · Received August 6, 2025

    Report

    Report Number
    3014833750-2025-00012
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    August 9, 2023
    Report Date
    August 6, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    HSN
    UDI-DI
    00840097505060
    PMA / PMN Number
    K192778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TIBIA IS LOOSENING MOST LIKELY DUE TO THE FACT THAT THE IMPLANT WAS NOT PROPERLY SEATED OR PATIENT FACTORS SUCH AS BONE QUALITY OR LIKELIHOOD OF INGROWTH. DURING THE INITIAL SURGERY, IT WAS NOTED THAT THERE WAS DIFFICULTY SEATING THE IMPLANT FULLY, WHICH MAY HAVE BEEN DUE TO IMPROPER SURGICAL TECHNIQUE OR PATIENT BONE BEING TOO HARD, AMONG MANY OTHER POSSIBLE CAUSES. IMPROPER SEATING CAN CONTRIBUTE TO LACK OF INGROWTH AND SUBSEQUENT LOOSENING. ANALYSIS OF PRODUCTION RECORDS REVEALS NO ABNORMAILITIES THAT COULD CONTRIBUTE TO THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    SURGEON REPORTED THE PATIENT'S TIBIAL IMPLANT SHOWS SIGNS OF LOOSENING AND THAT THEY FEEL PAIN IN THE AFFECTED JOINT. AFTER A SCOPE PROCEDURE AND CHECKING FOR SOFT TISSUE IMPINGEMENT, THE PATIENT WILL BE CONVERTED TO A REVISION TIBIAL AND TALAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288515 KINOS TOTAL ANKLE SYSTEM TOTAL ANKLE REPLACEMENT HSN RESTOR3D, INC. 1831.1120 2022100034 00840097505060

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention