BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 6, 9MM

    MDR report key: 20095169 · Received August 29, 2024

    Report

    Report Number
    1038671-2024-03161
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 12, 2024
    Report Date
    July 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (B)(6) 02-012-60-1440 - TRU STEM EXT 14MM X 40MM (B)(6) 02-020-11-0360 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 6 (B)(6) 02-022-45-6050 - TRULIANT TIB FIT TRAY CEM SZ 6F / 5T (B)(6) 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT (B)(6) 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK (B)(6) 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK (B)(6) 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK (B)(6) - GPS IMPLANT KIT V2

    Additional Manufacturer Narrative · 0

    H6: CORRECTED INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT UNDERWENT A POLY SWAP SECONDARY TO MIDFLEXION INSTABILITY. 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
    1911502 TRULIANT TIB IMP PSC INSERT SZ 6, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention