BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM

    MDR report key: 19616318 · Received June 26, 2024

    Report

    Report Number
    1038671-2024-02139
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    May 23, 2022
    Report Date
    October 3, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001771
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (B)(6), 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5; (B)(6), 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T; (B)(6), 200-02-32 - THREE PEG PATELLA 32MM. MANUFACTURER NARRATIVE UPDATED: 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. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 8 YEARS, 11 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
    625888 LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention