BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 5 10MM

    MDR report key: 19463814 · Received June 4, 2024

    Report

    Report Number
    1038671-2024-01735
    Event Type
    Injury
    Date Received
    June 4, 2024
    Report Date
    June 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304629
    PMA / PMN Number
    K111400
    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

    CONCOMITANTS: 5734326 02-020-11-0350 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 5 6150751 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T 6220867 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T 360341 02-029-99-1001 - FLUTED HEADLESS PIN 3.0" SQUARE HEAD 5886524 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT 6040022 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT S028629 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207045 TRULIANT TIB IMP PS INSERT SZ 5 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11