BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 11 MM

    MDR report key: 22360001 · Received June 30, 2025

    Report

    Report Number
    1038671-2025-02393
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: (B)(6), 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5. (B)(6), 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. (B)(6), 200-02-29 - THREE PEG PATELLA 29MM. H3: 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

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 8 YEARS POST INITIAL SURGERY. THE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. THE PATIENT HAS A RECALLED POLYETHYLENE IMPLANT. THE PATIENT UNDERWENT A TIBIAL POLYETHYLENE IMPLANT SWAP AND A PATELLA IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849445 LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 11 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability