BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL PLATE FB SZ 2 RT

    MDR report key: 16655283 · Received March 31, 2023

    Report

    Report Number
    1038671-2023-00558
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    March 1, 2023
    Report Date
    July 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276186
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCT(S): 6886384, 350-04-02 - FLAT CUT TALUS SZ 2 R; A168490, 350-10-02 - ANKLE SZ 2 LOCKING CLIP; 5719693, 350-22-02 - TIBIAL INSERT FB SZ 2 RT 6MM; 6858393, 351-90-20 - TUBERCLE PIN POUCH; 6871658, 351-90-21 - 3.5" PIN POUCH; 6871663, 351-90-21 - 3.5" PIN POUCH; A181050, 351-90-22 - 2.5" PIN POUCH.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. THE REVISION REPORTED WAS LIKELY DUE TO TIBIAL LOOSENING SECONDARY TO PATIENT¿S REPORTED POOR BONE QUALITY, FAILURE TO GAIN ADEQUATE BONE IN-GROWTH WITHIN THE CENTRAL CAGE, AND POTENTIAL CONTRIBUTIONS FROM NON-CEMENTED USAGE. 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 58 YEAR OLD FEMALE PATIENT HAD AN INITIAL TOTAL ANKLE ARTHROPLASTY ON (B)(6) 2022. THE PATIENT PRESENTED WITH A FAILED TIBIAL COMPONENT AND HAD IMMEDIATE PAIN, SWELLING, AND CYST FORMATION. THE PATIENT WAS REVISED ON (B)(6) 2023. THE VANTAGE TOTAL ANKLE IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. CULTURES WERE TAKEN. NO INFECTION. CUSTOM CAGE IMPLANT BEING MADE FOR AN ANKLE FUSION. THE REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505862 TIBIAL PLATE FB SZ 2 RT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 350-12-02 10885862276186

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention