BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 20941704 · Received December 16, 2024

    Report

    Report Number
    1038671-2024-04852
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    December 10, 2024
    Report Date
    May 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: (B)(6) 02-020-13-0235 - TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5 (B)(6) 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T (B)(6) 200-02-32 - THREE PEG PATELLA 32MM THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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 THAT THIS PATIENT'S KNEE WAS REVISED. PATIENT STATED THAT HIS KNEE WAS "AMPUTATED" BECAUSE OF THE KNEE REPLACEMENT AS THERE WERE MONTHS OF PERMANENT NERVE DAMAGE. IN ADDITION, HE CAN'T HEAR IN THE LEFT EAR. HE ALSO REPORTED A FEW INCHES OF SCARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601757 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1