BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FB SZ 1 LT 6MM

    MDR report key: 24547012 · Received March 9, 2026

    Report

    Report Number
    1038671-2026-00242
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 9, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276216
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 350-01-01 - TALAR IMPLANT SZ 1 LT: (B)(6). 350-10-02 - ANKLE SZ 2 LOCKING CLIP: (B)(6). 350-11-02 - TIBIAL PLATE FB SZ 2 LT: (B)(6). 351-90-20 - TUBERCLE PIN POUCH: (B)(6). 351-90-21 - 3.5" PIN POUCH: (B)(6). 351-90-22 - 2.5" PIN POUCH: (B)(6). 351-90-24 - TALAR TRIAL SCREW POUCH: (B)(6). 351-91-03 - RECIP SAWBLADE 8X50X1MM: 289020. 351-91-04 - SAW-10X75X1.19-STRYKER: 001568. 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

    THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL ANKLE ARTHROPLASTY. THE PATIENT LATER PRESENTED TO THE SURGEON¿S OFFICE WITH PAIN AND POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608741 TIBIAL INSERT FB SZ 1 LT 6MM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862276216

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization SEE H11.