BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 23166185 · Received September 29, 2025

    Report

    Report Number
    1038671-2025-02991
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    June 9, 2022
    Report Date
    September 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-01-0230 - FEMUR PS CEM.Nº3 IZQ.: 6874456. 02-012-35-3011 - LOGIC PS INSERTO TIBIAL 3-11MM: Z080138. 02-012-45-3030 - BANDEJA TIBIAL LOGIC FIT 3F/3T: 6961746. 200-02-32 - ROTULA TRES TETONES 32MM: 6848406. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REASON FOR THE JOINT EFFUSION REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL KNEE REPLACEMENT. SUBSEQUENTLY, THEY HAD A KNEE EFFUSION AND UNDERWENT AN ARTHROCENTESIS PROCEDURE. THE OUTCOME IS CONSIDERED RESOLVED. THE DEVICES REMAIN IMPLANTED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525535 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization SEE H11.