BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT POR TIB TRAY SIZE 3.5F/3.5T

    MDR report key: 21054866 · Received January 2, 2025

    Report

    Report Number
    1038671-2025-00007
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    August 1, 2022
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862317162
    PMA / PMN Number
    K182346
    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

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-00066. D10: CONCOMITANTS: (B)(6), 02-020-12-0235 - TRULIANT PS POR FEM PS POR LEFT SZ 3.5; (B)(6), 02-022-55-3535 - TRULIANT POR TIB TRAY SIZE 3.5F/3.5T; (B)(6), 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, FEMORAL 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 13 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, AMBULATION OR POSTURAL DIFFICULTIES, JOINT LAXITY, FAILURE OF IMPLANT, SCAR TISSUE, SYNOVITIS, PAIN AND SWELLING/ EDEMA. 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
    1322825 TRULIANT POR TIB TRAY SIZE 3.5F/3.5T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862317162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H