BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 2.5, 9 MM

    MDR report key: 15569371 · Received October 10, 2022

    Report

    Report Number
    1038671-2022-01271
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    December 8, 2020
    Report Date
    January 27, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306326
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM 6512163, 02-020-13-0235 - TRULIANT CR CEM FEM CR CEM LEFT SZ 3.5 6214474, 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T 6449532, 200-02-38 - THREE PEG PATELLA 38MM 6529909, 204-70-00 - TIBIAL STEM EXT. SCREW 6605741, CONCOMITANT MEDICAL PRODUCTS: Z-0023-2022.

    Additional Manufacturer Narrative · 0

    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 STIFFNESS, DECREASED RANGE OF MOTION AND PAIN CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION OF ARTHROFIBROSIS.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2020. THE PATIENT PRESENTED WITH LEFT KNEE STIFFNESS, DECREASED ROM, AND PAIN. ACTION TAKEN: MEDICATION. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511930 TRULIANT TIB IMP CR INS STD SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-022-47-2509 10885862306326

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other SEE H10