BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 25072591 · Received May 4, 2026

    Report

    Report Number
    1038671-2026-00534
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    February 12, 2020
    Report Date
    May 4, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-012-38-2509 - LOGIC RBK INSERTO TIBIAL SZ 2.5, 9MM (B)(6). 02-010-01-0225 - FEMUR PS CEM.Nº2.5 IZQ. 6218055 (B)(6). 02-012-43-2515 - LOGIC BANDEJA TIBIAL RBK SZ 2.5F/ 1.5T (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

    IT WAS REPORTED VIA A CLINICAL STUDY THAT THE PATIENT UNDERWENT A KNEE REPLACEMENT. SUBSEQUENTLY, THE PATIENT DEVELOPED AN INFECTION, INCLUDING ACUTE SEPTIC KNEE ARTHRITIS. A REVISION OF THE TIBIAL INSERT WAS PERFORMED (CAPTURED IN CASE-(B)(4)). APPROXIMATELY 3 MONTHS POST REVISION SURGERY, THE PATIENT WAS TREATED WITH MEDICATION TO MANAGE THE INFECTION. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28950 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1