BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 19651097 · Received July 1, 2024

    Report

    Report Number
    1038671-2024-02243
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 23, 2024
    Report Date
    October 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174673
    PMA / PMN Number
    K121307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT: (B)(6), 200-02-41 - THREE PEG PATELLA 41MM. (B)(6), 02-010-04-0260 - LOGIC CR FEMORAL POR, LEFT, SZ 6. (B)(6), 02-012-45-6060 - LGC TIBIAL FIT TRAY CEM SZ 6F / 6T. (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. (B)(6), A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2018. APPROXIMATELY 5 YEARS AND 8 MONTHS LATER, ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO PROSTHESIS WEAR. AT THIS TIME, THE TIBIAL INSERT AND PATELLA COMPONENT WERE REVISED. THIS FIRST REVISION IS CAPTURED IN CASE (B)(4). APPROXIMATELY 1 MONTH FOLLOWING THE FIRST REVISION, ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY ¿DUE TO INFECTION¿ AND A WASH OUT WAS PERFORMED. ONLY THE INSERT WAS REPLACED. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. A REVIEW OF THE STERILE CERTIFICATES FOR THE TIBIAL INSERT AND THE PATELLA COMPONENT WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION.

    Description of Event or Problem · 0

    APPROXIMATELY A MONTH AFTER A LEFT KNEE REPLACEMENT, THE PATIENT WAS REVISED DUE TO INFECTION. THE PATIENT WAS WASHED OUT. THE LINER WAS EXCHANGED. THE EVENT IS NOT RELATED TO A 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. UNABLE TO OBTAIN DEVICE IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996615 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174673

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention SEE H11