BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA ARC LT SZ 2 LG 3DP STRL

    MDR report key: 25255432 · Received May 22, 2026

    Report

    Report Number
    3008650117-2026-00242
    Event Type
    Injury
    Date Received
    May 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    PARAGON 28
    Product Code
    HSN
    PMA / PMN Number
    K192994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) B3: EVENT DATE OCCURRED AT AN UNKNOWN DAY IN DECEMBER 2025. D10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS IN THE D10 NARRATIVE BELOW. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - P10-250-TLL2-S, TALUS, CHAMFER, LEFT, SIZE 2, TPS (260F3002317). - P10-310-1206-S, CROSS-LINKED VITAMIN E POLY, SIZE 2 X 6MM, NEUTRAL (260819123A01). G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE RECONSTRUCTION. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN AND SWELLING ABOVE THE ANKLE APPROXIMATELY 10 MONTHS POST-IMPLANTATION. X-RAY REPORTEDLY DEMONSTRATED STABLE COMPONENTS WITH A LOCALIZED DISCRETE ANTERIOR LUCENCY. AT 13 MONTHS POST-IMPLANTATION A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED, AND LOW-IMPACT ACTIVITY WAS RECOMMENDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611823 TIBIA ARC LT SZ 2 LG 3DP STRL PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN PARAGON 28 NI 260F1862307

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other SEE H11 NARRATIVE.