BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 24775707 · Received April 3, 2026

    Report

    Report Number
    1038671-2026-00373
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    October 10, 2023
    Report Date
    April 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    02-010-01-0225 - LOGIC FEMORAL PS CEM LEFT SZ 2.5: (B)(6). 02-012-35-2511 - LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM: (B)(6). 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T: (B)(6). 200-02-29 - THREE PEG PATELLA 29MM: (B)(6). 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 BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 6 DAYS AFTER THE PATIENT'S DEBRIDEMENT AND SKIN CLOSURE PROCEDURE FOR SUPERFICIAL WOUND DEHISCENCE, A DEFECT OF ABOUT 3X5 CM IS OBSERVED, WHICH DID NOT CURRENTLY EXPOSE THE PROSTHESIS, BUT DISSECTS MEDIALLY. NEGATIVE PRESSURE THERAPY WAS ADMINISTERED. 3 DAYS LATER NEGATIVE PRESSURE THERAPY IS WITHDRAWN, AND CURES ARE CARRIED OUT EVERY 7 DAYS UNTIL 1 MONTH AND 3 DAYS LATER, WHEN THE DISSOLUTION IS CLOSED. THE OUTCOME IS CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21576 LOGIC KNEE COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R SEE H11.