BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT MB SZ 1 RT 7MM

    MDR report key: 20600085 · Received November 4, 2024

    Report

    Report Number
    1038671-2024-04221
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    October 23, 2024
    Report Date
    May 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 350-32-01 - TIBIAL PLATE MB SZ 1 RT 4970933 350-02-01E - TALUS -RIGHT- SZ 1 - EU 5121414.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE EVENT INVOLVED A DEVICE THAT IS NOT MARKETED IN THE UNITED STATES, NOR HAS A SIMILAR MARKETED DEVICE IN THE UNITED STATES. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE TO THE FDA AND THIS REPORT MAY BE DISREGARDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF INSTABILITY, PROSTHESIS WEAR, AND FRACTURE OF THE TIBIAL INSERT. THE FRACTURE LIKELY RESULTED FROM HIGH IN VIVO LOADING ON THE ANTEROMEDIAL ASPECT OF THE IMPLANT, WHICH LED TO A CRACK WHICH PROPAGATED ACROSS THE INSERT, ULTIMATELY LEADING TO DEVICE FRACTURE. THE SEQUENCE OF EVENTS AS RELATED TO THE REPORTED WEAR, FRACTURE, AND INSTABILITY CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT ANKLE HAD AN INLAY STRESS FRACTURE DUE TO INLAY ABRASION. NO FURTHER INFORMATION RECEIVED. PRODUCT NOT RETURNING: STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161150 TIBIAL INSERT MB SZ 1 RT 7MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention SEE H11