BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL PLATE FB SZ 3 RT

    MDR report key: 18941304 · Received March 20, 2024

    Report

    Report Number
    1038671-2024-00589
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    August 31, 2023
    Report Date
    March 10, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    UDI-DI
    10885862276193
    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) CONCOMITANT DEVICE(S): 350-22-22 - TIBIAL INSERT FB SZ 2 RT 8MM: 4748658. 350-02-02 - TALAR IMPLANT SZ 2 RT: 5231652. 350-10-03 - ANKLE SZ 3 LOCKING CLIP: 5184595. (H3) PENDING EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, THE 33-YEAR-OLD FEMALE PATIENT HAD A RIGHT TAA ON (B)(6) 2018. ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN STATING SHE NOTICED SOME DISCOMFORT DURING THE PREVIOUS WINTERTIME. SHE STATED HER ANKLE IS DOING WELL WITH MINIMUM PAIN AND ASYMPTOMATIC MOST DAYS. ON (B)(6) 2023, DR. (B)(6) ORDERED CT SCAN BECAUSE SHE HAD COMPLAINTS LATERALLY AND HER X-RAYS SHOWED SOME GROWTH OF THE CYST IN THAT AREA. ON (B)(6) 2023, DR. (B)(6) STATED THAT THE SUBJECT DESCRIBED HER PAIN AS ACHING AND BURNING, MORE INTENSE WITH ACTIVITY. THE SYMPTOMS ARE AGGRAVATED BY STANDING, WALKING, AND WEIGHT BEARING. DR. (B)(6) ELECTED TO PROCEED WITH REVISION. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED BY ACTION OF REVISION ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928663 TIBIAL PLATE FB SZ 3 RT PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC. 10885862276193

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female SEE H10.