BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 23118070 · Received September 22, 2025

    Report

    Report Number
    1038671-2025-02966
    Event Type
    Injury
    Date Received
    September 22, 2025
    Report Date
    October 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6, H11. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE EVENT CANNOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: (B)(6), 02-012-45-5050 - BANDEJA TIBIAL LOGIC FIT 5F/5T, (B)(6), 02-010-03-0350 - LOGIC FEMUR CR CEMENTADO Nº5 DER. (B)(6), 02-012-47-5009 LOGIC CR TIB INSERT STD, SZ 5, 9MM. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED HAD POOR CLINICAL COURSE FROM THE BEGINNING AND UNDERWENT A MANIPULATION UNDER ANESTHESIA POSTOPERATIVELY. SUBSEQUENTLY THEY WERE REVISED AT A LATER DATE. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225435 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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