BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 2, 9MM

    MDR report key: 20248058 · Received September 18, 2024

    Report

    Report Number
    1038671-2024-03592
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    September 3, 2024
    Report Date
    August 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304896
    PMA / PMN Number
    K152170
    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

    PENDING INVESTIGATION. D10: 02-020-11-0220 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2, 5542756. 02-022-45-2020 - TRULIANT TIB FIT TRAY CEM SZ 2F/2T, 6478723. 200-02-32 - THREE PEG PATELLA 32MM, 6502571. 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6578989. 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK, 6122242. 203-96-67 - FAN SAWBLADE EZ2213F.M63 90X22 1.27MM STRKR 5/6/7, 250522. 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, S045200. 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK, S074582.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS AND 10 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO INSTABILITY. THE POLY WAS SWAPPED OUT AND SEEMED NORMAL. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319766 TRULIANT TIB IMP PSC INSERT SZ 2, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11.