BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 22311242 · Received June 23, 2025

    Report

    Report Number
    1038671-2025-02347
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    April 29, 2025
    Report Date
    August 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE EVENT CANNOT BE 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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 08010018020 A10012 - GPS IMPLANT KIT V2, (B)(6), 203-96-42 - (11-3671) STRYKER SYS 6 90X13/21X1.19, (B)(6), 203-96-42 - (11-3671) STRYKER SYS 6 90X13/21X1.19, (B)(6), 02-010-04-0220 - LOGIC CR FEMORAL POR, LEFT, SZ 2, (B)(6), 02-012-51-2011 - LOGIC TIB INSERT IMPL CRC, 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 FEMALE PATIENT, WHO HAD A LEFT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF KNEE PAIN. THE SURGEON REMOVED ALL COMPONENTS AND REPLACED THEM WITH A COMPETITOR¿S DEVICES. 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 AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE NOT AVAILABLE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063324 OPTETRAK LOGIC 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