BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 21698892 · Received March 26, 2025

    Report

    Report Number
    1038671-2025-01666
    Event Type
    Injury
    Date Received
    March 26, 2025
    Report Date
    April 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5: (B)(6); 02-012-35-2511 - LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM: (B)(6); 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T: (B)(6); 200-02-35 - THREE PEG PATELLA 35MM: (B)(6). 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 THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT IN (B)(6) 2014. SUBSEQUENTLY, THE PATIENT REPORTED THAT THE REPLACEMENT FAILED, AND A REVISION WAS SCHEDULED FOR (B)(6) 2025. IT IS UNKNOWN AT THIS TIME IF THE KNEE REVISION TOOK PLACE. NO FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S KNEE WILL NEED TO BE REVISED THIS YEAR. PATIENT STATED THAT THEY HAVE AN EXACTECH DEVICE THAT HAS FAILED, NECESSITATING ANOTHER SURGERY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804837 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O SEE H11