BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2 10MM

    MDR report key: 18785128 · Received February 26, 2024

    Report

    Report Number
    1038671-2024-00323
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    December 27, 2019
    Report Date
    February 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304070
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 02-020-11-0320 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2: 5827776 02-022-45-2010 - TRULIANT TIB FIT TRAY CEM SZ 2F / 1T: 5749423 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT: 5881932.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 55-YEAR-OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019 AND PRESENTED WITH OTHER-MUA, 1 MONTH(S) AND 0 YEAR(S) POST-OPERATIVELY ON (B)(6) 2019. PATIENT WASN'T GETTING DESIRED ROM. PATIENT DID PHYSICAL THERAPY AND STILL ONLY HAD 0-77 ROM. ANKYLOSIS RIGHT KNEE, CLOSED MANIPULATION UNDER ANESTHESIA RIGHT KNEE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON 27-DEC-2020, AND THE ACTION TAKEN WAS OTHER - MUA RIGHT KNEE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR 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
    111837 TRULIANT TIB IMP PS INSERT SZ 2 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304070

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male SEE H10