BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 19818934 · Received July 24, 2024

    Report

    Report Number
    1038671-2024-02503
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    January 31, 2023
    Report Date
    October 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304254
    PMA / PMN Number
    K152170
    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

    H10. RELATED: MFR #1038671-2022-01574 REPORT 1 OF 2. H11. ADDITIONAL MANUFACTURER NARRATIVE- REPORT 2 OF 2. D10. CONCOMITANT PRODUCTS: LOGIC STEM EXT 14MM X 25MM (CAT# 02-012-60-1425 / SERIAL#(B)(6). TRULIANT TIB FIT TRAY CEM SZ 3F / 3T (CAT# 02-022-45-3030 / SERIAL#(B)(6). ADVANCED PATELLA 32MM 3 PEG IMPLANT (CAT# 200-07-32 / SERIAL# (B)(6). TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 (CAT# 02-020-11-0330/ (B)(6). TIBIAL STEM EXT. SCREW (CAT# 204-70-00/ SN (B)(6). THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: - LOGIC STEM EXT 14MM X 25MM (CAT# 02-012-60-1425 / SERIAL# (B)(6)) - TRULIANT TIB IMP PS INSERT SZ 3 9MM (CAT# 02-022-35-3009 / SERIAL# (B)(6)) K152170 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T (CAT# 02-022-45-3030 / SERIAL# (B)(6)) - ADVANCED PATELLA 32MM 3 PEG IMPLANT (CAT# 200-07-32 / SERIAL# (B)(6)) -TIBIAL STEM EXT. SCREW (CAT# 204-70-00/ SN (B)(6)). H6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING, AS STATED IN THE LEGAL DOCUMENTATION AND CLINICAL STUDY. THE EXTENT OF THE REPORTED PROSTHESIS WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES, PRE-REVISION RADIOGRAPHS, AND OPERATIVE NOTES WERE UNABLE TO BE OBTAINED. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE. IT IS UNCLEAR IF THE REPORTED PROSTHESIS WEAR MAY HAVE CONTRIBUTED TO THE REPORTED FEMORAL LOOSENING OR IF THE FEMORAL LOOSENING CONTRIBUTED TO THE REPORTED PROSTHESIS WEAR.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 3 YEARS, 7 MONTHS POST INITIAL TKA, PATIENT HAD A REVISION DUE TO POLYETHYLENE WEAR AND FEMORAL LOOSENING. ADDITIONAL INFORMATION RECEIVED FROM LEGAL BRIEF INDICATES THAT FOLLOWING THE SURGERY, PATIENT BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PATIENT¿S PHYSICIAN DISCUSSED WITH PATIENT HIS CONCERNS REGARDING EARLY OXIDATION OF HER RECALLED EXACTECH POLYETHYLENE INSERT AND SUSPECTED FEMORAL LOOSENING. PATIENT WAS DIAGNOSED WITH ¿FAILED TOTAL RIGHT KNEE REPLACEMENT¿ SECONDARY TO HER RECALLED TRULIANT DEVICE AND WAS INFORMED OF HER NEED FOR A FULL REVISION SURGERY. PATIENT WAS SCHEDULED FOR A RIGHT KNEE REPLACEMENT REVISION SURGERY AND THEN RESCHEDULED. PER THE EVENT INFORMATION PROVIDED THE REVISION OCCURRED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349641 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862304254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11| SEE H11.