BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM

    MDR report key: 15067488 · Received July 20, 2022

    Report

    Report Number
    1038671-2022-00819
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    June 23, 2022
    Report Date
    March 9, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001849
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION CONCOMITANT DEVICE(S): 02-010-01-0235 LOGIC FEMORAL PS CEM LEFT SZ 3.5 4801857. 02-012-41-3525 LOGIC TIBIA TRAPTRAY CEM SZ 3.5F/2.5T 4761844. 200-02-32 THREE PEG PATELLA 32MM 5429765.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, AS REPORTED IN THE EXPERIENCE REPORT AND LEGAL DOCUMENTATION. BASED ON THE IMAGE PROVIDED OF THE REVISED INSERT, THERE APPEARS TO BE SOME MINOR DEFORMATION, SCRATCHING, AND/OR PITTING ON THE ARTICULAR SURFACE. THIS APPEARS UNREMARKABLE AND CONSISTENT WITH IMPLANTATION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 4755, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 66 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT BE RETURNING, HOSPITAL KEEPS ALL RETRIEVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980841 LOGIC TIBIA PS MOD INSRT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-35-3509 UNK 10885862001849

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R