BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 11MM

    MDR report key: 19191874 · Received April 26, 2024

    Report

    Report Number
    1038671-2024-00990
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    March 14, 2023
    Report Date
    November 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001818
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 2584040 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. 2830911 200-02-35 - THREE PEG PATELLA 35MM. 2857570 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3. 9Y088 203-96-03 - (11-2216) SAW BLADE NEW STRYKER (.050). 9Y090 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050). H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. THE CAUSE OF PROSTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2013 AND THEN WAS REVISED ON (B)(6) 2023. THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN IN HER LEFT KNEE, ALONG WITH SWELLING, INSTABILITY, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126628 LOGIC TIBIA PS MOD INSRT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention