BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 13MM

    MDR report key: 19946010 · Received August 8, 2024

    Report

    Report Number
    1038671-2024-02752
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 22, 2024
    Report Date
    March 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304476
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 5553653 02-010-06-0240 - TRU CC FEMORAL SIZE 4 LEFT. 5702064 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. 5930806 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM. 5282350 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T. 5835494 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. 6529292 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. 6580212 204-70-00 - TIBIAL STEM EXT. SCREW. 4858356 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM. 4858366 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM.

    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 #1038671-2023-02332.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS AND 10 MONTHS POST THE PREVIOUS LEFT REVISION, THE PATIENT WAS REVISED AGAIN BECAUSE THE PATELLA FELL OUT AND HAD TO BE BONE GRAFTED DUE TO OSTEOLYSIS OF THE PATELLA. THE PATIENT WILL REQUIRE AN ADDITIONAL SURGERY TO REPAIR THE PATELLA ONCE THE BONE GRAFT HAS GROWN NEW BONE. 30CC OF BONE GRAFT WAS USED TO GRAFT THE PATIENT'S PATELLA. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647653 TRULIANT TIB IMP PS INSERT SZ 4 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304476

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention