BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 9MM

    MDR report key: 19165588 · Received April 23, 2024

    Report

    Report Number
    1038671-2024-00951
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    February 27, 2024
    Report Date
    June 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304438
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REPORTED SURGICAL INTERVENTION 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 HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY ONE YEAR POST INITIAL LEFT TKA, THE 67 Y/O FEMALE PRESENTED WITH REDNESS, PATIENT HAD SWELLING LEFT KNEE. X-RAY SHOWED ANTERIOR SOFT TISSUE SWELLING, NARROW ZONES OF PERIPROSTHETIC LUCENCY. PATIENT WAS ADMITTED AND RX'D DAPTOMYCIN. THE SURGEON PERFORMED LTK REVISION FOR INCISION AND DRAINAGE WITH POLY EXCHANGE. PATIENT WAS DISCHARGED HOME SEVEN DAYS LATER WITH RX'D PAIN MEDICATION AND ASA X4 WEEKS AND ANTIBIOTIC X6 WEEKS. PER CLINICAL REPORT, THE REPORTED EVENT IS NOT RELATED TO THE DEVICE BUT DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946962 TRULIANT TIB IMP PS INSERT SZ 4 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 9MM UNKNOWN 10885862304438

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention ADVANCED PATELLA 35MM 3 PEG IMPLANT.| TRULIANT PS CEM FEM PS CEM LEFT SZ 4.| TRULIANT TRAY, CEM SZ 4F/3.5T.