BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 25018059 · Received April 28, 2026

    Report

    Report Number
    1038671-2026-00506
    Event Type
    Injury
    Date Received
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-020-13-0335 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5: 6545519. 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T: 6449541. 02-022-51-3513 - TRULIANT TIB IMP CRC INSERT SZ 3.5, 13MM: S030696. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: 6770999. 203-96-67 - FAN SAWBLADE EZ2213F.M63 90X22 1.27MM STRKR 5/6/7: 7248. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO HAD A RIGHT TKA, STATED THEY STARTED HAVING PAIN IN THEIR KNEE 3 MONTHS PRIOR AND WERE SEEN BY THEIR DOCTOR¿S PA. THE PATIENT WAS INFORMED ABOUT THE RECALL BUT WAS TOLD THERE WAS NO RECOURSE AT THIS TIME. THE PATIENT STATED THEY HAVE A FUTURE APPOINTMENT WITH THEIR DOCTOR AND EXPECTS THAT THE DEVICE WOULD NEED REPLACED. THE PATIENT IS CURRENTLY TAKING TYLENOL AND ADVIL AND WAS CONCERNED WITH LONG TERM USE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073163 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.