BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 22493077 · Received July 14, 2025

    Report

    Report Number
    1038671-2025-02487
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    July 15, 2022
    Report Date
    July 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304476
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF THE FEMORAL LOOSENING, PROSTHESIS WEAR OF THE TIBIAL INSERT, AND/OR DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. THE LOOSENING OF THE FEMORAL COMPONENT COULD NOT BE CONFIRMED BUT COULD BE THE RESULT OF A WEAKENED BIOLOGIC INTEGRATION OF THE FEMORAL COMPONENT AT THE BONE-IMPLANT INTERFACE. THE WEAR OF THE TIBIAL INSERT WAS LIKELY THE RESULT OF JOINT INSTABILITY AND/OR HIGH FLEXION CAUSING THE FEMORAL CAM TO ABNORMALLY ARTICULATE WITH THE TIBIAL SPINE. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0023-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. CONCOMITANTS: TRULIANT TIBIA INSERT PS SIZE 4 13MM - CN: (B)(4) / SN: (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, THIS 58-YEAR-OLD, MALE PATIENT HAD A LEFT INITIAL TKA. THE PRESS FIT FEMORAL COMPONENT SHOWED LOOSE ON A BONE SCAN AND THE PATIENT WAS REVISED. THE PATIENT WAS REVISED TO A CONSTRAINED SIZE 4 LEFT SIDE AND A SIZE 4/13MM PS LINER WITH A 18X80 CEMENTED STEM. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION. PHOTOS AND X-RAYS PROVIDED. THE DEVICES ARE RETURNING ON RG589738. 510K: K181794.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601702 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304476

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| H SEE H11