BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT MB SZ 3 RT 6MM

    MDR report key: 18682414 · Received February 9, 2024

    Report

    Report Number
    1038671-2024-00196
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 25, 2024
    Report Date
    June 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    OYK
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED HEALTH EFFECT - CLINICAL CODE AND COMPONENT CODE. MANUFACTURER NARRATIVE UPDATED: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND OSTEOLYSIS. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND OSTEOLYSIS COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND OSTEOLYSIS. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND OSTEOLYSIS COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF BONE CYST FORMATION AS STATED IN THE REPORT, SUSPECTED PROSTHESIS WEAR, AND POSTERIOR MIGRATION OF THE TALAR COMPONENT. THE REPORTED PROSTHESIS COULD NOT BE CONFIRMED FROM THE AVAILABLE INFORMATION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IMAGES OF THE EXPLANTED COMPONENTS WERE NOT PROVIDED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4 UDI NUMBER.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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

    AS REPORTED, AFTER IMPLANTATION OF A CEMENTLESS ANKLE JOINT ENDOPROSTHESIS ON (B)(6) 2020, EXCESSIVE INLAY WEAR AND BONE CYSTS ON THE TIBIA AND TALUS WERE FOUND. IN (B)(6) 2022, THE COMPANY REPORTED MISSING OXIDATION BARRIER OF THE PACKAGING WITH THE POSSIBLE CONSEQUENCE OF INLAY DAMAGE WHEN STORED FOR > 5 YEARS. ALTHOUGH NO INLAYS THAT HAVE BEEN STORED FOR > 5 YEARS HAVE BEEN IMPLANTED IN GERMANY, THE REPORT IS MADE PRECAUTIONARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109653 TIBIAL INSERT MB SZ 3 RT 6MM ANKLE ARTHROPLASTY IMPLANTATION SYSTEM OYK EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other