BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 23002639 · Received September 9, 2025

    Report

    Report Number
    1038671-2025-02896
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 8, 2025
    Report Date
    December 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6. THE FOLLOWING SECTIONS WERE CORRECTED: B5, H6.

    Additional Manufacturer Narrative · 0

    D10: 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4: (B)(6). 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T: (B)(6). 200-02-41 - THREE PEG PATELLA 41MM: (B)(6). 02-012-48-4009 - LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM: (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 THAT THIS PATIENT'S RIGHT KNEE REPLACEMENT WAS REVISED DUE TO PAIN AND OSTEOLYSIS. THE SURGEON REPLACED THE CONSTRUCT AND REPLACED IT WITH A COMPETITOR'S DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE REPLACEMENT WAS REVISED DUE TO OSTEOLYSIS. THE SURGEON REPLACED THE CONSTRUCT AND REPLACED IT WITH A COMPETITOR'S DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333159 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization SEE H11.