BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 19802394 · Received July 22, 2024

    Report

    Report Number
    1038671-2024-02474
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 7267078 02-022-35-3509 - TRULIANT TIB IMP PS INSERT SZ 3.5 9MM, 7056117 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5, 7143106 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T, A179589 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT, A226430 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, A136805 201-78-81 - 3" TROCAR, MOD. HEX 2PK, A247151 201-78-81 - 3" TROCAR, MOD. HEX 2PK, S363958 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, S381506 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK.

    Description of Event or Problem · 0

    APPROXIMATELY 1.5 YEARS AFTER INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THE SURGEON USED ZIMMER FOR THE REVISION. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483695 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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