BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 2, 11MM

    MDR report key: 18279511 · Received December 6, 2023

    Report

    Report Number
    1038671-2023-02923
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    March 21, 2023
    Report Date
    July 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306289
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): (B)(6): 02-020-13-0320 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 2. (B)(6): 02-022-45-2020 - TRULIANT TIB FIT TRAY CEM SZ 2F / 2T. (B)(6): 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE EVENT CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. D4: CORRECTED H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 69 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT PRESENTED ON (B)(6) 2023 WITH TRICOMPARTMENTAL DEGENERATIVE CHANGES WITH LATERAL JOINT SPACE NARROWING, SCLEROSING AND OSTEOPHYTE FORMATION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME IS CONTINUING. PATIENT WAS HAVING DISCOMFORT; PAIN WAS RELATED MORE TO THE JOINT CAPSULE AND NOT THE HARDWARE. PATIENT DECLINED ELECTIVE REVISION SURGERY. TOPICAL ANESTHETIC CREAM WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258488 TRULIANT TIB IMP CR INS STD SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862306289

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female