BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 22092709 · Received May 27, 2025

    Report

    Report Number
    1038671-2025-02173
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    February 13, 2020
    Report Date
    May 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 02-020-11-0345 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5: (B)(6). 02-022-44-4510 - TRULIANT TIB IMP PSC INSERT SZ 4.5, 10MM: (B)(6). 02-022-45-4535 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T: (B)(6). 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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 THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE, THEN A CLOSED MANIPULATION UNDER ANESTHESIA FOR STIFFNESS, APPROXIMATELY 2 MONTHS POST OPERATIVELY. SUBSEQUENTLY, THE PATIENT IS NOW EXPERIENCING INFLAMMATION WITH PAIN AND STIFFNESS. AS A RESULT, APPROXIMATELY 1 YEAR AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT ASPIRATION TO THE RIGHT KNEE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331244 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H11