BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 24671208 · Received March 23, 2026

    Report

    Report Number
    1038671-2026-00312
    Event Type
    Injury
    Date Received
    March 23, 2026
    Report Date
    March 23, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304254
    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: 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 (B)(6). 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T (B)(6). 200-02-32 - THREE PEG PATELLA 32MM (B)(6). 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK (B)(6). 203-96-64 - SAWBLADES EZ1913.M62 90X19, 1.27MM STRKR5/6/7 (B)(6). 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK (B)(6). 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK (B)(6). 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 FEMALE PATIENT, WHO HAD A LEFT TKA, UNDERWENT A REVISION PROCEDURE. THE SURGEON CONTACTED THE PATIENT REQUESTING THEY GET A POLY SWAP. THE PREVIOUSLY IMPLANTED POLY WAS EXPLANTED AND REPLACED WITH A DIFFERENT SIZE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL WOULD NOT RELEASE THEM. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732423 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11.