BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2.5 9MM

    MDR report key: 15588046 · Received October 12, 2022

    Report

    Report Number
    1038671-2022-01299
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 21, 2022
    Report Date
    December 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304162
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 02-020-11-0325 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 2.5 6963683, 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T 6994175, 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT 6777251. RECALL: Z-0023-2022.

    Additional Manufacturer Narrative · 0

    H3: 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 FOR PAIN CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2021. THE PATIENT COMPLAINED OF PAIN AND HAD UNSATISFACTORY ISSUES WITH THE KNEE IMPLANTS. DUE TO THE RECALL, THE PATIENT WAS REVISED ON (B)(6) 2022. THE SURGEON USED COMPETITOR IMPLANTS FOR THE REVISION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2896320 TRULIANT TIB IMP PS INSERT SZ 2.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-022-35-2509 10885862304162

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H SEE H10