BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 13MM

    MDR report key: 16609022 · Received March 24, 2023

    Report

    Report Number
    1038671-2023-00504
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    July 29, 2021
    Report Date
    March 24, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001788
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED CONCOMITANT MEDICAL PRODUCTS: LOGIC FEMORAL PS CEM RIGHT SZ 2.5 (CAT#: 02-010-01-0325 / SERIAL#: (B)(4). LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T (CAT#: 02-012-45-2515 / SERIAL#: (B)(4). THREE PEG PATELLA 35MM (CAT#: 2794905 / SERIAL#: (B)(4). DEVICE EVALUATED BY MFR: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THE ADVERSE EVENT COULD HAVE BEEN THE RESULT OF FACTORS SUCH AS OTHER PROCEDURES, MEDICATIONS, OTHER INTERVENTIONS, TRAUMA, ACCIDENT, OR THE SUBJECT'S PRE-EXISTING MEDICAL CONDITIONS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2021, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY 1 AND ONE-HALF MONTHS AFTER THE FIRST REVISION OF THE RIGHT EXACTECH KNEE DEVICE WITH POLYETHYLENE LINER EXCHANGE AND IRRIGATION AND DEBRIDEMENT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377073 LOGIC TIBIA PS MOD INSRT SZ 2.5 13MM SEE H10 JWH EXACTECH, INC. 02-012-35-2513 10885862001788

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention