BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    MDR report key: 16237158 · Received January 24, 2023

    Report

    Report Number
    1038671-2023-00067
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    December 22, 2022
    Report Date
    March 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304346
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 5043192, 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM, 4890435, 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5, ,4761715, 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F/2.5T, 5011117, 200-02-32 - THREE PEG PATELLA 32MM, 5020656, 204-70-00 - TIBIAL STEM EXT. SCREW. 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 CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, WITH A 3.5/9 MM EXACTECH TRULIANT PS POLYETHYLENE TIBIAL INSERT, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020, APPROXIMATELY 3 YEARS 3 MONTHS POST THE INITIAL PROCEDURE TO REMOVE THE FAILED POLYETHYLENE LINER DUE TO A ¿FAILED RIGHT TOTAL KNEE REPLACEMENT. DURING PLAINTIFF¿S REVISION SURGERY, PLAINTIFF¿S ORTHOPEDIC SURGEON ENCOUNTERED ¿INFLAMMATORY HYPERTROPHY OF THE SYNOVIAL LINING¿ AS WELL AS A MODERATE AMOUNT OF ¿SYNOVIAL FLUID.¿ THE POLYETHYLENE LINER WAS REMOVED, AND A SYNOVECTOMY WAS CARRIED OUT. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033598 TRULIANT TIB IMP PS INSERT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 9MM UNK 10885862304346

    Patients

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