BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM

    MDR report key: 15626464 · Received October 18, 2022

    Report

    Report Number
    1038671-2022-01320
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    February 27, 2015
    Report Date
    May 20, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173843
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 2136093 02-010-01-0360 - LOGIC FEMORAL PS CEM RIGHT SZ 6, 1950695 02-012-45-6050 - LGC TIBIAL FIT TRAY CEM SZ 6F / 5T, 3805456 200-02-38 - THREE PEG PATELLA 38MM.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) 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 PAIN CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED VIA LEGAL THAT THIS MALE PATIENT'S KNEE WAS CAUSING PAIN 7.5 YEARS POST OP. REVISION SURGERY HAS BEEN RECOMMENDED, BUT NOT SCHEDULED. NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT'S KNEE WAS CAUSING PAIN 7.5 YEARS POST OP. REVISION SURGERY HAS BEEN RECOMMENDED, BUT NOT SCHEDULED. NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL THAT THIS MALE PATIENT'S KNEE WAS CAUSING PAIN 7.5 YEARS POST OP. REVISION SURGERY HAS BEEN RECOMMENDED, BUT NOT SCHEDULED. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478764 LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-44-6011 UNK 10885862173843

    Patients

    Seq Age Sex Outcome Treatment
    1