BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB FIT TRAY CEM SZ 5F / 5T

    MDR report key: 20745757 · Received November 21, 2024

    Report

    Report Number
    1038671-2024-04459
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    January 16, 2023
    Report Date
    November 21, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305947
    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

    1038671-2023-01346. D10: CONCOMITANTS: (B)(6), 660-01-10 - OSSILIX / FORM 10CC CALCIUM PHOSPHATE; (B)(6), 02-012-60-2012 - TRU STEM EXT 20MM X 120MM; (B)(6), 02-010-06-0250 - TRU CC FEMORAL SIZE 5 LEFT; (B)(6), 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM; (B)(6), 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM; (B)(6), 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM; (B)(6), 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM; (B)(6), 208-05-05 - CC DISTAL FEM AUGMENT SZ 5, 5MM; (B)(6), 200-02-38 - THREE PEG PATELLA 38MM; (B)(6), 02-012-60-1212 - TRU STEM EXT 12MM X 120MM; (B)(6), 204-70-00 - TIBIAL STEM EXT. SCREW; (B)(6), 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, PATELLAR LOOSENING, AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REVISION, APPROXIMATELY 62 MONTHS AFTER THEIR INITIAL PROCEDURE. THERE WAS FOUND TO BE A LOOSE TIBIAL COMPONENT WITH A COMPLETELY LOOSE TIBIAL STEM. THERE WAS FOUND TO BE A MODERATE AMOUNT OF POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE. THERE WAS EVIDENCE OF POLYETHYLENE WEAR AND SYNOVIAL ENCAPSULATION. THERE WAS A HETEROTOPIC BONE FORMED AROUND THE PATELLA WITH A LOOSE PATELLAR COMPONENT. THE PATIENT ALSO HAD DEVELOPED A PRETIBIAL GANGLION CYST DUE TO THE LOOSE TIBIAL COMPONENT RUBBING UP AGAINST THE ANTERIOR CORTEX OF HIS MID LEFT TIBIA. 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
    2448446 TRULIANT TIB FIT TRAY CEM SZ 5F / 5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862305947

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H