BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 22629299 · Received July 28, 2025

    Report

    Report Number
    1038671-2025-02602
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 4, 2025
    Report Date
    August 29, 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: H6, H11. 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 MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, AND/OR PATIENT RELATED FACTORS. 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. D10: (B)(6) 02-010-04-0235 - LOGIC CR FEMORAL POR, LEFT, SZ 3.5. (B)(6) 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. (B)(6) 02-012-48-3509 - LOGIC TIBIAL INSERT SLOPE +. SZ 3.5, 9 MM. (B)(6) 200-02-35 - THREE PEG PATELLA 35MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 YEARS AND 9 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653489 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization SEE H11.