BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 11MM

    MDR report key: 17240023 · Received June 30, 2023

    Report

    Report Number
    1038671-2023-01516
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    November 4, 2022
    Report Date
    April 22, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304278
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THIS PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 6449567, 02-020-12-0330 - TRULIANT PS POR FEM PS POR RIGHT SZ 3. 6338559, 02-022-55-3030 - TRULIANT POR TIB TRAY SIZE 3F/3T. 6546974, 200-02-32 - THREE PEG PATELLA 32MM. S088630, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. S088637, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. 8034720103, A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT (B)(6) 2020. THEY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 1 YEAR 11 MONTHS AFTER THEIR INITIAL PROCEDURE. (B)(6) 2022 OP REPORT STATES THAT THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID AND WELL-FIXED FEMORAL, TIBIAL, AND PATELLAR COMPONENTS. THERE WAS A MILD TO MODERATE AMOUNT OF VISIBLE POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE. THERE WAS ALSO EVIDENCE OF A MILD AMOUNT OF POLYETHYLENE DEBRIS WITHIN SYNOVIAL ENCAPSULATION. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26078 TRULIANT TIB IMP PS INSERT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-022-35-3011 UNK 10885862304278

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention SEE H10