BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 19577203 · Received June 20, 2024

    Report

    Report Number
    1038671-2024-02049
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 17, 2023
    Report Date
    October 28, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001177
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2024-01943. CORRECTION: PLEASE DISREGARD THIS REPORT AS IT WAS REPORTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT #1038671-2024-01943.

    Additional Manufacturer Narrative · 0

    RELATED: MFR #1038671-2024-01943 REPORT 1 OF 2. ADDITIONAL MANUFACTURER NARRATIVE- REPORT 2 OF 2. D10. CONCOMITANTS: 1619428 02-012-39-5060 - LOGIC TIBIA FIN TRAY CEM SZ 5F/6T. 1682897 201-78-11 - HOLDING PIN SMALL HEADED SHORT 4 PACK. 1843705 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK). 1863044 200-02-32 - THREE PEG PATELLA 32MM. 1728582 02-012-35-5009 - LOGIC TIBIA PS MOD INSRT SZ 5 9MM. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE LEFT KNEE AND THEN APPROXIMATELY 12 YEARS, 8 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED ABOUT THE PATIENT THAT THEY HAD ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210554 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.