BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4, 9MM

    MDR report key: 23720716 · Received December 4, 2025

    Report

    Report Number
    1038671-2025-03484
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-020-13-0340 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 4: (B)(6). 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T: (B)(6). 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY AND PAIN. AS A RESULT, THE PATIENT UNDERWENT A REVISION WHERE THE SURGEON PERFORMED A POLY INSERT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422836 TRULIANT TIB IMP CRC INSERT SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization SEE H11.