BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 9MM

    MDR report key: 24490063 · Received March 2, 2026

    Report

    Report Number
    1038671-2026-00212
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    September 7, 2022
    Report Date
    March 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304438
    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

    D10: 6222387, 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T. 6190986, 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. 6220029, 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4. THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN. THE DEFORMATION MARKS ON THE TIBIAL INSERT APPEAR CONSISTENT WITH COMING IN CONTACT WITH SURGICAL TOOLS DURING THE REVISION SURGERY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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

    AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. DUE TO RECALL SURGEON USED A COMPETITOR FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING, DUE TO RECALL HOSPITAL WILL NOT RELEASE THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549720 TRULIANT TIB IMP PS INSERT SZ 4 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304438

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R