BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC TIBIAL INSERT

    MDR report key: 19559883 · Received June 18, 2024

    Report

    Report Number
    1038671-2024-01962
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    November 9, 2019
    Report Date
    October 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862613325
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11. PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 02-012-61-6000 - TRU OFFSET STEM EXT COUPLER, 6MM 4996577 02-010-66-1002 - METAPHYSEAL FEMORAL CONE, SMALL, H42MM 5336474 02-012-64-1480 - TRU FLUTED STM EXT 14MM X 80MM BLAST 5892677 02-010-06-0220 - TRU CC FEMORAL SIZE 2 LEFT 6061618 H4: CORRECTED.

    Additional Manufacturer Narrative · 0

    D: ADDED PRODUCT INFORMATION FOR MEDICAL SUSPECT DEVICE. THE REASON THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE LEFT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072262 OPTETRAK LOGIC TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862613325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention