BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL PLATE FB SZ 1 LT

    MDR report key: 24234962 · Received February 2, 2026

    Report

    Report Number
    1038671-2026-00107
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    July 29, 2022
    Report Date
    February 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276131
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 350-21-01 - TIBIAL INSERT FB SZ 1 LT 6MM: (B)(6). 350-10-01 - ANKLE SZ 1 LOCKING CLIP: (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND LOOSENING OF THE TIBIAL PLATE. AS A RESULT, THE PATIENT UNDERWENT AN ANKLE REVISION APPROXIMATELY 2 YEARS AND 9 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299109 TIBIAL PLATE FB SZ 1 LT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862276131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11.