BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 21847814 · Received April 16, 2025

    Report

    Report Number
    1038671-2025-01834
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    March 14, 2025
    Report Date
    July 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED; (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED; (B)(6), 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; (B)(6), 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS; (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK; (B)(6), 02-012-47-2009 - LOGIC CR TIB INSERT STD, SZ 2, 9MM; (B)(6), 02-010-04-0220 - LOGIC CR FEMORAL POR, LEFT, SZ 2; (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK; (B)(6), 201-78-81 - 3 TROCAR, MOD. HEX 2PK; (B)(6), 200-02-35 - THREE PEG PATELLA 35MM; (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3: THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED IN (B)(4) CANNOT BE CONCLUSIVELY DETERMINED OR CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. H6, H7, H9. THE FOLLOWING SECTIONS WERE CORRECTED: H6: CODES 4756, 4118, 3233, 11 NO LONGER APPLY. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED, A FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2021, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 4 YEARS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH KNEE PAIN. THE SURGEON REMOVED ALL COMPONENTS AND REPLACED WITH A COMPETITOR¿S KNEE IMPLANTS. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114629 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention SEE H11