BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIBIAL INSERT

    MDR report key: 24463294 · Received February 26, 2026

    Report

    Report Number
    1038671-2026-00197
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 6, 2026
    Report Date
    February 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-010-03-0335 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3.5: (B)(6), 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T: (B)(6), 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T: (B)(6), 02-012-48-3509 - LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM: (B)(6), 02-012-49-3511 - LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM: (B)(6), 200-02-38 - THREE PEG PATELLA 38MM: (B)(6), 200-02-38 - THREE PEG PATELLA 38MM: (B)(6). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A RIGHT KNEE ARTHROPLASTY. POSTOPERATIVELY, THE PATIENT DEVELOPED SIGNIFICANT OSTEOLYSIS SECONDARY TO POLYETHYLENE WEAR AND COMPONENT LOOSENING. THE PATIENT TOLERATED THE SUBSEQUENT SURGERY WELL, WITH NO REPORTED COMPLICATIONS. ALL COMPONENTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516060 LOGIC CR TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization SEE H11