BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT MB SZ 3 RT 8MM

    MDR report key: 19762030 · Received July 17, 2024

    Report

    Report Number
    1038671-2024-02418
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    July 11, 2024
    Report Date
    April 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    OYK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10:: 5667032 350-02-03E - TALUS -RIGHT- SZ 3 - EU. 5333493 350-32-03 - TIBIAL PLATE MB SZ 3 RT.

    Additional Manufacturer Narrative · 0

    H3: THE REASON FOR THE RADIOGRAPHIC MARKER DISASSEMBLY REPORTED COULD NOT BE CONCLUSIVELY DETERMINED. PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE DISASSEMBLY; HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND IMAGES OF THE DEVICE WERE NOT AVAILABLE AS IT REMAINS IMPLANTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B3, H6 PROBLEM CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A TOTAL ANKLE REPLACEMENT PROCEDURE, A PATIENT EXPERIENCED MIGRATION OF A RADIOGRAPHIC MARKER FOR A TIBIAL INSERT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040347 TIBIAL INSERT MB SZ 3 RT 8MM ANKLE ARTHROPLASTY IMPLANTATION SYSTEM OYK EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11