BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE

    MDR report key: 20146992 · Received September 5, 2024

    Report

    Report Number
    1038671-2024-03320
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    December 18, 2023
    Report Date
    November 6, 2024
    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

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): (B)(6) 200-02-35 - THREE PEG PATELLA 35MM. (B)(6) 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4. (B)(6) 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T.

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED IN CASE-(B)(4) MAY HAVE BEEN THE RESULT OF LOOSENING, PROSTHESIS WEAR, AND OSTEOLYSIS. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONE. BASED ON THE IMAGES PROVIDED, THERE DOES NOT APPEAR TO BE EXCESSIVE WEAR OF THE INSERT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 53 Y/O FEMALE PATIENTS RIGHT KNEE WAS REVISED 1.5 YEARS POST OP. THE PATIENT WAS REVISED DUE TO OSTEOLYSIS, LOOSENING AND POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PRODUCT RETURN; DISPOSED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865112 LOGIC KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention