BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT MB SZ 1 LT 6MM

    MDR report key: 24584510 · Received March 12, 2026

    Report

    Report Number
    1038671-2026-00257
    Event Type
    Injury
    Date Received
    March 12, 2026
    Report Date
    March 12, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 350-01-01E - TALUS - LEFT - SZ 1 - EU: 6476748. 350-31-02 - TIBIAL PLATE MB SZ 2 LT: 6861865. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT TAA, UNDERWENT A REVISION PROCEDURE. THE PATIENT REPORTED SEVERE PAIN DURING A WALK WHICH HE SOON COMMUNICATED THE INCONVENIENCE TO THE SURGEON, AND HE REQUESTED A CT SCAN AND RX TO EVALUATE THE SITUATION. AT THE RADIOLOGICAL CONTROL THE JOINT LINE SEEMED THINNED OUT WITH RESPECT TO THE STANDARD SITUATION, AND THE CT SCAN SHOWED A PIECE OF POLYETHYLENE IN THE ANKLE BACK SIDE. THE PATIENT WAS REVISED TO A TIBIAL INSERT OF SAME SIZE WITH HEIGHT OF 7MM. THERE WAS BREAKAGE OF THE LINER REPORTED. THE FRONTAL PART OF THE LINER WAS REMOVED EASILY WITH A CLAMP; THE POSTERIOR PART WAS REMOVED USING THE TIBIAL TUBERCLE PIN SCREWED INTO THE LINER. THERE WAS A 5-15 MINUTE DELAY WITH NO ADVERSE EVENT TO THE PATIENT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGING WAS PROVIDED. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646310 TIBIAL INSERT MB SZ 1 LT 6MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H