BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    MDR report key: 19281658 · Received May 9, 2024

    Report

    Report Number
    1038671-2024-01169
    Event Type
    Injury
    Date Received
    May 9, 2024
    Report Date
    May 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304346
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 4060079 200-02-35 - THREE PEG PATELLA 35MM, 5037097 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T, 5099910 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5, 5161269 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T, 5207515 02-022-35-3509 - TRULIANT TIB IMP PS INSERT SZ 3.5 9MM, 5224035 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5, 5232932 204-70-00 - TIBIAL STEM EXT. SCREW, 5233128 204-70-00 - TIBIAL STEM EXT. SCREW, 5233407 200-02-35 - THREE PEG PATELLA 35MM, 5261912 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM, 5261943 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL SHORT FORM THAT APPROXIMATELY 74 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY NEED A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520847 TRULIANT TIB IMP PS INSERT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10