BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 3.5, 10MM

    MDR report key: 19234390 · Received May 2, 2024

    Report

    Report Number
    1038671-2024-01029
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    January 15, 2024
    Report Date
    November 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305176
    PMA / PMN Number
    K171045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: SERIAL NUMBER ITEM NUMBER AND FULL DESCRIPTION (B)(6) 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM (B)(6) 02-012-50-3511 - TRU TIB AUG 1/2 SZ 3.5, 5MM (B)(6) 02-012-50-3511 - TRU TIB AUG 1/2 SZ 3.5, 5MM (B)(6) 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM (B)(6) 02-012-61-6000 - TRU OFFSET STEM EXT COUPLER, 6MM (B)(6) 02-012-64-1680 - TRU FLUTED STM EXT 16MM X 80MM BLAST (B)(6) 02-012-64-1680 - TRU FLUTED STM EXT 16MM X 80MM BLAST (B)(6) 02-010-06-0532 - TRU POST. AUG. SIZE 3, 10MM (B)(6) 02-010-06-0531 - TRU POST. AUG. SIZE 3, 5MM (B)(6) 02-010-06-0330 - TRU CC FEMORAL SIZE 3 RIGHT (B)(6) 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T (B)(6) 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 30 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450216 TRULIANT TIB IMP PSC INSERT SZ 3.5, 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862305176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.