BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 20733809 · Received November 20, 2024

    Report

    Report Number
    1038671-2024-04439
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    November 11, 2024
    Report Date
    February 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B2, B3, B5, D1, D6A, D6B, D10, E1, E2, E3, G2, H6 CLINICAL CODE, IMPACT CODE, AND PROBLEM CODE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. CONCOMITANTS: 02-010-04-0335 FEMORAL COMPONENT CR, POROUS SIZE 3.5 (B)(6). 02-012-45-3535 FIT TIBIAL TRAY CEMENTED SIZE 3.5F/3.5T (B)(6). 02-012-48-3509 TIBIAL INSERT CR, SIZE 3.5, 9MM SLOPE + (B)(6). 200-02-38 THREE PEG PATELLA, 38MM (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF JOINT SWELLING AND PAIN. HOWEVER, THIS CANNOT BE CONFIRMED AND CONTRIBUTIONS FROM PATIENT, USER, OR DEVICE RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED 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.

    Additional Manufacturer Narrative · 0

    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 DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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

    AS REPORTED, APPROXIMATELY 8 YEARS AND 8 MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT PRESENTED WITH PAIN AND SWELLING. A REVISION WAS PERFORMED AND EVERYTHING WAS REMOVED. THE SURGEON ADVISED THAT THERE WAS A LOT OF FLUID REMOVED DURING SURGERY. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE PATIENT CONTACTED EXACTECH AND REPORTED CONSISTENT PAIN IN THEIR KNEES AND IS UNABLE TO HAVE THEIR KNEES REPLACED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938910 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| H SEE H11.