BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 3.5, 11MM

    MDR report key: 19727197 · Received July 11, 2024

    Report

    Report Number
    1038671-2024-02369
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 18, 2024
    Report Date
    December 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305190
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: A864076, 02-012-60-1425 - TRU STEM EXT 14MM X 25MM; A964001, 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5; A792813, 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T; A983887, 02-029-90-4300 - STERILE PACKED SHORT HEADED PIN; A567203, 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT; A504267, 204-70-00 - TIBIAL STEM EXT. SCREW; S381600, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK; S532757, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK; S526331, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK; S528303, 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK; 12000323022, A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS A QUAD RUPTURE AND ALSO AN INCIDENTAL POLY EXCHANGE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346887 TRULIANT TIB IMP PSC INSERT SZ 3.5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862305190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.