BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 9MM

    MDR report key: 15498750 · Received September 28, 2022

    Report

    Report Number
    1038671-2022-01176
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 6, 2025
    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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 7026253, 02-020-11-0230 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3; 7120598, 02-022-45-3025 - TRULIANT TRAY, CEM SZ 3F/2.5T; 6982890, 200-02-32 - THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE KNEE INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT RETURNED TO HER DOCTOR¿S OFFICE TO COMPLAINING ABOUT LEFT KNEE INSTABILITY. THE SURGEON REPLACED THE LINER WITH A THICKER POLY TO STABILIZE THE KNEE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICES ARE NOT RETURNING, THEY WERE DISPOSED OF BY THE FACILITY. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633597 TRULIANT TIB IMP PS INSERT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-022-35-3009 10885862304254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10.