BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT MB SZ 1 LT 7MM

    MDR report key: 22312372 · Received June 23, 2025

    Report

    Report Number
    1038671-2025-02355
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    June 17, 2025
    Report Date
    September 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    OYK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. D10: (B)(6), 350-01-01E - TALUS - LEFT - SZ 1 - EU, (B)(6), 350-31-02 - TIBIAL PLATE MB SZ 2 LT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5, D9, H6, H11 THE FOLLOWING SECTIONS WERE CORRECTED: H6 THE COMPLAINT DEVICE WAS EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. THE EVALUATION IDENTIFIED THE TALAR ARTICULATING SURFACE OF THE LINER APPEARS TO HAVE PITTING AND SCRATCHING CONSISTENT WITH THIRD BODY WEAR DURING ARTICULATION. THERE APPEARS TO BE AREAS OF EXTENSIVE WEAR AND SURFACE DELAMINATION, AS WELL AS DISPLACED POLYETHYLENE. THIS DAMAGE PATTERN MAY HAVE BEEN CAUSED POST-FRACTURE, WHERE THE POSTERIOR HALF OF THE LINER WOULD HAVE BEEN IN CONTACT WITH TALAR BONE, AND THE ANTERIOR HALF WOULD HAVE BEEN IN CONTACT WITH THE TALAR NECK AND TALAR COMPONENT FLANGE. THE TIBIAL PLATE ARTICULATING SURFACE OF THE LINER APPEARS TO HAVE PITTING AND SCRATCHING CONSISTENT WITH THIRD BODY ARTICULATION. THERE APPEARS TO BE LARGE TACTILE SCRATCHES, WHICH MAY BE RESULTING REMOVAL DAMAGE. THE MEDIAL AND LATERAL SIDES APPEAR TO HAVE CRACK INITIATION. THE MEDIAL AND LATERAL SIDES OTHERWISE APPEAR UNREMARKABLE. THE ANTERIOR AND POSTERIOR HALVES OF THE LINER APPEAR TO HAVE TOOL DAMAGE ON THEIR SURFACES. THE RADIOGRAPHIC MARKER IN THE POSTERIOR HALF IS FLUSH WITH THE POSTERIOR FACE. THERE APPEARS TO BE MEDIAL STRESS WHITENING, WHICH IS INDICATIVE OF PREFERENTIALLY MEDIAL LOADING. THE LINER THINNING MAY BE THE RESULT OF A COMBINATION OF WEAR AND POLYETHYLENE CREEP, A PHENOMENON OF POLYETHYLENE DEFORMATION OVER TIME UNDER A SUSTAINED LOAD, SUCH AS BODY WEIGHT DURING GAIT. PROVIDED RADIOGRAPHS APPEAR UNREMARKABLE WITH REGARDS TO IMPLANT PLACEMENT. THERE APPEARS TO BE A COMPETITOR METAL WEDGE IN THE PATIENT'S MIDFOOT ANATOMY. AS SHOWN IN ONE RADIOGRAPH, THE GAP BETWEEN THE TIBIAL PLATE AND THE TALAR COMPONENT APPEARS SMALLER THAN THAT OF ANOTHER RADIOGRAPH. THIS MAY BE AN INDICATION OF DEVICE WEAR. AS SHOWN IN ANOTHER RADIOGRAPH, THERE IS LITTLE-TO-NO GAP BETWEEN THE TIBIAL PLATE AND TALAR COMPONENT. THE RADIOGRAPHIC MARKER OF THE LINER HAS SHIFTED POSTERIOR AS A RESULT OF THE LINER FRACTURE. ALL OTHER ASPECTS OF THE DEVICES APPEAR UNREMARKABLE. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT OCCURRED DUE TO LINER WEAR AND CREEP WHICH SUBSEQUENTLY RESULTED IN LINER FRACTURE. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS COULD NOT BE EVALUATED. 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, THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY APPROXIMATELY 4 YEARS AND 11 MONTHS AGO, WITH COTTON OSTEOTOMY TO MEDIAL CUNEIFORM. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS BACK TO WALKING AND STANDING FOR SEVERAL HOURS EASILY. THE PATIENT WAS SEEN 4 YEARS LATER AND EVERYTHING WAS GOOD; NO X-RAYS WERE TAKEN. THE PATIENT WAS SEEN AGAIN RECENTLY AND EXPERIENCED NO SYMPTOMS, BUT A POLY FRACTURE WAS FOUND ON THE ROUTINE CHECK X-RAY. THE PATIENT IS SCHEDULED FOR A POLY EXCHANGE NEXT WEEK. NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY APPROXIMATELY 4 YEARS AND 11 MONTHS AGO, WITH COTTON OSTEOTOMY TO MEDIAL CUNEIFORM. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS BACK TO WALKING AND STANDING FOR SEVERAL HOURS EASILY. THE PATIENT WAS SATISFACTORY UNTIL 3 YEARS LATER, WHEN THEY NOTICED SOME VAGUE DISCOMFORT AFTER PROLONGED STANDING. THIS SETTLED. THE PATIENT WAS SEEN AGAIN 4 YEARS POST-OP AND EVERYTHING WAS GOOD; NO X-RAYS WERE TAKEN. THE PATIENT WAS SEEN AGAIN RECENTLY AND EXPERIENCED NO SYMPTOMS, BUT A POLY FRACTURE WAS FOUND ON THE ROUTINE CHECK X-RAY. THE PATIENT IS SCHEDULED FOR A POLY EXCHANGE NEXT WEEK. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427084 TIBIAL INSERT MB SZ 1 LT 7MM ANKLE ARTHROPLASTY IMPLANTATION SYSTEM OYK EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization SEE H11.