BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 4, 9MM

    MDR report key: 18725508 · Received February 16, 2024

    Report

    Report Number
    1038671-2024-00249
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    December 21, 2018
    Report Date
    September 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 02-010-06-0340 - LOGIC CC FEMORAL SIZE 4, RIGHT 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2024-00236.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 62 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON 13-NOV-2018 AND PRESENTED WITH INFECTION, 0 YEAR(S) AND 1 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2018. 12-11-2018 MILD SWELLING, MODERATE PAIN; (B)(6) 2019: MODERATE SWELLING, ARTHROCENTESIS REVEALED +STAPHYLOCOCCUS PANEL. REVISION SCHEDULE (B)(6) 2019. REFERRED TO ID. IV ABX THERAPY X 6 WEEKS. REVISION SCHEDULED (B)(6) 2019. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION TAKEN WAS REVISION ON (B)(6) 2019. THE OUTCOME IS REPORTED AS RESOLVED ON (B)(6) 2019. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389197 TRULIANT TIB IMP PSC INSERT SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male SEE H10.