BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 15MM

    MDR report key: 19341899 · Received May 17, 2024

    Report

    Report Number
    1038671-2024-01315
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    January 29, 2024
    Report Date
    March 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304490
    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

    D10: CONCOMITANT DEVICES: 4833336 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T. 4871993 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. 4902749 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. 4935789 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4. 4994770 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. 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.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND PATELLAR LOOSENING AND FEMORAL 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. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PREMATURE POLYETHYLENE WEAR FROM RECALLED POLYETHYLENE INSERT, ASEPTIC LOOSENING OF FEMORAL AND PATELLAR COMPONENTS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743308 TRULIANT TIB IMP PS INSERT SZ 4 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304490

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention SEE H10