BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 3.5, 11 MM

    MDR report key: 18279544 · Received December 6, 2023

    Report

    Report Number
    1038671-2023-02924
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    March 21, 2023
    Report Date
    February 12, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): (B)(6): 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. (B)(6): 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T . (B)(6): 200-02-35 - THREE PEG PATELLA 35MM. (B)(6): 02-020-13-0335 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 70 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT PRESENTED ON (B)(6) 2023 WITH PAIN AND STIFFNESS IN BOTH KNEES, ONLY RIGHT IS EXACTECH. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO DEVICE AND/OR TO PROCEDURE. OUTCOME IS CONTINUING. ARTHROSCOPIC LYSIS OF ADHESIONS RECOMMENDED BUT NOT DONE. POLY IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222032 TRULIANT TIB IMP CR INS STD SZ 3.5, 11 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female SEE H10