BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 23250392 · Received October 8, 2025

    Report

    Report Number
    1038671-2025-03063
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    January 31, 2023
    Report Date
    October 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-06-0330 - TRU CC FEMORAL SIZE 3 RIGHT 452828202-010-06-0531 - TRU POST. AUG. SIZE 3, 5MM 441711702-012-44-3013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM 415260602-012-45-3040 - LGC TIBIAL FIT TRAY CEM SZ 3F / 4T 456463702-012-60-1440 - TRU STEM EXT 14MM X 40MM 464548902-012-60-1812 - TRU STEM EXT 18MM X 120MM 462038702-012-66-2000 - METAPHYSEAL TIBIAL CONE, ML32MM 4679743200-02-32 - THREE PEG PATELLA 32MM 4636598204-70-00 - TIBIAL STEM EXT. SCREW 4595894208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM 4008876208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM 4670437208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM 4734650208-10-15 - CC FEMORAL AUG SCREW 15MM 2303806SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED A 64 YO MALE PATIENT, WHO HAD RTKA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. ALL BUT THE TIBIAL COMPONENTS ASIDE FROM THE POLY WERE REVISED. REASON FOR THE REVISION IS UNKNOWN AT THIS TIME. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE, BUT A SURGICAL DELAY OF GREATER THAN 45 MINUTES WAS REPORTED ¿ DELAY DUE TO REVISION INDICATED. THERE WAS NO ADVERSE EVENT TO THE PATIENT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE WERE KEPT BY THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508816 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention