BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSERT

    MDR report key: 16798734 · Received April 24, 2023

    Report

    Report Number
    1038671-2023-00803
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    July 18, 2017
    Report Date
    January 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001856
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 4021110 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5, 4145745 02-012-35-3511 - LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM, 4250769 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 4143146 200-02-32 - THREE PEG PATELLA 32MM.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 4021110, 02-010-01-0335 - LOGIC FEMORAL PS CEM RIGHT SZ 3.5; 4250769, 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T; 4143146, 200-02-32 - THREE PEG PATELLA 32MM. H6. INVESTIGATION RESULTS - LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM, WITH SN (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, ON OR ABOUT ON (B)(6) 2016, THIS PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HER RIGHT KNEE. AT SOME POINT AFTERWARD, SHE PRESENTED FOR AN EVALUATION OF HER RIGHT KNEE, AS SHE HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. ON OR ABOUT ON (B)(6) 2017, APPROXIMATELY 1 YEAR AND 5 MONTHS AFTER THEIR REPLACEMENT SURGERY, THE PATIENT PRESENTED FOR AN ARTHROSCOPY AND COMPLETE SYNOVECTOMY IN ATTEMPT TO RELIEVE HER PAIN. 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
    1936792 LOGIC TIBIA PS MOD INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862001856

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention