BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 22533183 · Received July 17, 2025

    Report

    Report Number
    1038671-2025-02513
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    November 11, 2019
    Report Date
    September 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) THE FOLLOWING SECTIONS WERE CORRECTED: B3. THE REPORTED MANIPULATION UNDER ANESTHESIA ON LEFT TKA CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO PATIENT FACTORS/ETIOLOGY, COMPONENT POSITIONING, ARTHROFIBROSIS, INFECTION AND/OR IMPLANT SELECTION. THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: 02-020-14-0235 - TRULIANT CR POR FEM CR POR LEFT SZ 3.5: (B)(6) 02-022-51-3512 - TRULIANT TIB IMP CRC INSERT SZ 3.5,12MM: (B)(6). 02-022-55-3535 - TRULIANT POR TIB TRAY SIZE 3.5F/3.5T: (B)(6). 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ARTHROFIBROSIS IN LEFT KNEE. AS A RESULT, APPROXIMATELY 4 MONTHS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA. PATIENT RETURNED TO CLINIC FOR FOLLOW-UP AND INDICATED THAT LEFT TKA IS DOING WELL. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748726 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization SEE H11