BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

    MDR report key: 19571088 · Received June 19, 2024

    Report

    Report Number
    1038671-2024-02022
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    November 6, 2023
    Report Date
    October 15, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862064042
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11. D10. CONCOMITANTS - PRODUCT INFORMATION: 1717697-244-03-04 - OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT; 2194066-200-02-38 - THREE PEG PATELLA 38MM; 2220331-200-04-45 - CEMENTED FINNED TIB. TRA SZ 4F/5T PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THE DEVICES WERE IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED FAILURE(S). HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED AND 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. H6: CORRECTED COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK CLASSIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 11 YEARS, 9 MONTHS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577344 OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862064042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.