BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 11MM

    MDR report key: 16880770 · Received May 5, 2023

    Report

    Report Number
    1038671-2023-00918
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    January 27, 2023
    Report Date
    September 15, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304360
    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

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: CONCOMITANTS: 5040345 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5 4927039 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T 5100233 200-02-35 - THREE PEG PATELLA 35MM 4971588 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 4982916 204-70-00 - TIBIAL STEM EXT. SCREW.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. THE EXTENT AND ROOT CAUSE OF THE REPORTED PROSTHESIS WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2017. PATIENT HAD RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 5 YEARS 3 MONTHS AFTER THEIR INITIAL REPLACEMENT. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE POLYETHYLENE DUE TO PREMATURE WEAR AND POLYETHYLENE RECALL, AS WELL AS LOOSE FEMORAL COMPONENT. THERE WAS FOUND TO BE VISIBLE EVIDENCE OF POLYETHYLENE WEAR WITH ENCAPSULATED POLYETHYLENE DEBRIS OF THE SYNOVIUM. THERE WAS FOUND TO BE A LOOSE FEMORAL COMPONENT AND WELL-FIXED TIBIAL AND PATELLAR COMPONENTS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691877 TRULIANT TIB IMP PS INSERT SZ 3.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-022-35-3511 UNK 10885862304360

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention