BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 9MM

    MDR report key: 21262766 · Received January 29, 2025

    Report

    Report Number
    1038671-2025-00508
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    January 9, 2025
    Report Date
    May 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304438
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXINS REPORT WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR SURGICAL PROCEDURE. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL RISK, AS OUTLINED IN THE IFU. H6: CORRECTED INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T 6680364. 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 7053256. 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT A095104. H3: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 2 YEARS 4 MONTHS POST OPERATION. THE PATIENT HAD INFECTION PRESENT. SURGEON SCHEDULED THE PATIENT FOR AN IRRIGATION AND DEBRIDEMENT OF THEIR RIGHT TOTAL KNEE ARTHROPLASTY WITH A TIBIAL POLY INSERT SWAP. THE TOTAL JOINT WAS EXPOSED, IRRIGATED, AND DEBRIDED. A SYNOVECTOMY WAS PERFORMED. THE TIBIAL POLY INSERT WAS REPLACED WITH A NEW ONE. ANTIBIOTIC BEADS WERE PLACED LOCALLY INTO THE WOUND. THE JOINT WAS CLOSED AND THE PATIENT LEFT THE OR STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819038 TRULIANT TIB IMP PS INSERT SZ 4 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304438

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention SEE H11.