BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM

    MDR report key: 19629243 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02184
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 18, 2018
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312617
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANTS: 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T: 5144981. 02-020-13-0235 - TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5: 5232370. 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT: 5354747.

    Description of Event or Problem · 0

    AS REPORTED VIA CLINICAL STUDY APPROXIMATELY 1 MONTH AFTER A TOTAL KNEE REPLACEMENT, PATIENT UNDERWENT REVISION PROCEDURE TO ADDRESS, KNEE PAIN, SWELLING, POPPING, INABILITY TO FULLY EXTEND KNEE, AND RUPTURE OF LEFT PATELLAR TENDON. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215463 TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862312617

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female SEE H11