BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC TIBIAL INSERT

    MDR report key: 19455593 · Received June 3, 2024

    Report

    Report Number
    1038671-2024-01709
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    December 7, 2023
    Report Date
    October 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144416
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: SN: (B)(6), 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5; SN: (B)(6), 200-02-29 - THREE PEG PATELLA 29MM; SN: (B)(6), 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. THE REASON FOR THE REVISION REPORTED IN CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149839 OPTETRAK LOGIC TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862144416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK.