BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 15769830 · Received November 10, 2022

    Report

    Report Number
    1038671-2022-01438
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    September 10, 2020
    Report Date
    February 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306340
    PMA / PMN Number
    K170240
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED DUE TO CLINICAL STUDY POLICY. CONCOMITANT MEDICAL PRODUCTS: 02-020-13-0225 - TRULIANT CR CEM FEM CR CEM LEFT SZ 2.5, (B)(4). 02-022-45-2535 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 3.5T, (B)(4). 201-78-81 - 3" TROCAR, MOD. HEX 2PK, (B)(4). BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY PATIENT-RELATED CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 74 YO OBESE FEMALE PATIENT, WHO WAS INITIALLY IMPLANTED WITH A LEFT KNEE ON (B)(6) 2017, FOR THE PRIMARY INDICATION OF OSTEOARTHRITIS, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL IMPLANT PROCEDURE. DATE OF ONSET, (B)(6) 2020. THE STUDY INDICATES INFLAMMATION, DEFINITELY NOT RELATED TO DEVICES OR PROCEDURE. THE TIBIAL INSERT WAS REVISED, AND LABS SENT FROM LEFT KNEE FLUID. OUTCOME INDICATES RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857044 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 2.5, 13 MM UNK 10885862306340

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention UNK.