BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIBIAL INSERT

    MDR report key: 19570905 · Received June 19, 2024

    Report

    Report Number
    1038671-2024-02020
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    October 12, 2021
    Report Date
    October 3, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304360
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11. PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    D10: (B)(6), 201-78-80 - 3" TROCAR, HEX 2PK; (B)(6), 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5; (B)(6), 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T; (B)(6), 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT; (B)(6), 201-78-80 - 3" TROCAR, HEX 2PK; (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; (B)(6), 201-78-80 - 3" TROCAR, HEX 2PK. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A TRULIANT DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550316 TRULIANT TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention