BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 24953409 · Received April 22, 2026

    Report

    Report Number
    1038671-2026-00488
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    October 11, 2020
    Report Date
    April 21, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-020-11-0245, TRULIANT PS CEM FEM PS CEM LEFT SZ 4.5: 6108345. 02-022-35-4509, TRULIANT TIB IMP PS INSERT SZ 4.5 9 MM: M012820. 02-022-45-4545, TRULIANT TIB FIT TRAY CEM SZ 4.5F/4.5T: 6455661. 200-02-38, THREE PEG PATELLA 38 MM: 6185206. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A CLINICAL STUDY, THAT A MALE PATIENT, WHO HAD A LEFT TKA, REPORTED THAT AFTER WORK, HIS KNEE LOCKED UP AND HE HAD SIGNIFICANT SWELLING. HE WENT TO THE ED AND HAD A CT SCAN AND XRAYS. THE CT FINDINGS SHOWED A LEFT KNEE ARTHROPLASTY WITH METALLIC OPACITY FEMORAL AND TIBIAL COMPONENTS WITH PROMINENT BEAM HARDENING AND STREAK EFFECTS ARTIFACT, LIMITING EVALUATION. THERE IS NO GROSS DISRUPTION OR DISLOCATION OF THE COMPONENTS IDENTIFIED. AREAS OF CURVILINEAR LUCENCY ABOUT THE MARGINS OF THE TIBIAL COMPONENT AND STEM AND LESS PROMINENTLY ABOUT THE FEMORAL COMPONENT, AND AREAS OF LOOSENING COULD BE DIFFICULT TO APPRECIATE AND DIFFERENTIATE. LARGE JOINT EFFUSION. SOFT TISSUE PROMINENCE SWELLING. CONTUSION IMPACTION INJURY AND SOFT TISSUE INJURY INTERNAL DERANGEMENT COULD BE DIFFICULT TO APPRECIATE. CORRELATE CLINICALLY. THEY WERE CONCERNED ABOUT A QUAD TENDON RUPTURE AND PLACED HIM IN A KNEE IMMOBILIZER. THE REPORT INDICATED IT WAS UNLIKELY RELATED TO THE DEVICE, BUT POSSIBLE RELATED TO THE PROCEDURE. THE OUTCOME INDICATED RESOLVED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011585 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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