BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 18463189 · Received January 8, 2024

    Report

    Report Number
    1038671-2024-00028
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    October 13, 2022
    Report Date
    October 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304346
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 6808699 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5 6866704 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T AB7316 13A2101 - CEMEX SYSTEM FAST GENTA 70G 6981243 200-02-35 - THREE PEG PATELLA 35MM S308739 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK S308742 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK PENDING INVESTIGATION

    Additional Manufacturer Narrative · 0

    H3. INVESTIGATION RESULTS- THE CAUSE OF THE PATIENT¿S RANGE OF MOTION, NICKEL ALLERGY, AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. METAL SENSITIVITY REACTIONS OR OTHER ALLERGIC/HISTOLOGICAL REACTIONS TO IMPLANT MATERIALS AND RANGE OF MOTION ARE MENTIONED IN THE IFU. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2021. APPROXIMATELY 1 YEAR AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON 13 OCT 2022 DIAGNOSIS: RIGHT KNEE FAILURE FROM INFLAMMATORY RESPONSE TO NICKEL, MECHANICAL ALIGNMENT DIFFERING FROM NATIVE ANATOMIC ALIGNMENT LIMITING FLEXION AND EXTENSION. AT INTRA-OPERATIVE INSPECTION, THE RIND OF SCAR TISSUE SURROUNDING THE IMPLANT WAS CONFIRMED AND COMPLETE SYNOVECTOMY PERFORMED. THE PATIENT WAS REMOVED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Description of Event or Problem · 0

    THERE WERE NO MARKERS FOR INFECTION. THE PATIENT SHOWED EVIDENCE OF NICKEL ALLERGY CONFIRMED BY LTT TESTING. EXACTECH COMPONENTS ALIGNED AT 5 DEGREE IR, 3 DEG ANTERIORLY SLOPED TIBIAL. CORRECTED TO 9 DEG DFA, 0 DEG POSTERIO TIBIAL SLOPE. THE PATELLA WAS IN EXCELLENT CONDITION, THERE WAS NO LOOSENING OF THE FEMORAL COMPONENT. INSPECTION OF THE FEMUR SHOWED FIBROUS TISSUE/SYNOVIUM INGROWTH BETWEEN THE CEMENT AND THE METAL IMPLANT. THE PATIENT WAS REMOVED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO MENTION OF DEVICE MALFUNCTION OR WEAR IN THE REVISION OPERATIVE REPORT. THE PATIENT WAS REVISED TO COMPETITOR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621005 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862304346

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Required Intervention SEE H10