BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 16274399 · Received January 31, 2023

    Report

    Report Number
    1038671-2023-00087
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    November 10, 2022
    Report Date
    May 7, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001825
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 4062128 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3, 4069174 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T, 3907010 200-02-29 - THREE PEG PATELLA 29MM, 2275472 02-012-35-3013 - LOGIC TIBIA PS MOD INSRT SZ 3 13MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE AND/OR PATIENT-RELATED CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND OSTEOLYSIS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, PROSTHESIS WEAR CANNOT BE CONFIRMED AS THE RADIOGRAPHS DO NOT SHOW SIGNS OF WEAR AND AN IMAGE OF THE ARTICULATING SURFACE OF THE INSERT WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A POWER POINT PRESENTATION, THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE, DATE UNKNOWN. THE PATIENT HAD DONE WELL, BUT DEVELOPED PAIN, SWELLING, AND ¿CRACKLING¿ IN BOTH KNEES IN 2021. IMPLANTS REVISED DUE TO THEIR SUBSEQUENT FAILURE. THE LEFT KNEE WAS REVISED TO A COMPETITOR¿S DEVICES. SUMMARY OF PRESENTATION OF 5 PATIENTS: THE VAST MAJORITY (>90%) OF PATIENTS ARE NOT EXPERIENCING SYMPTOMS. SYMPTOMS INCLUDE PAIN, SWELLING, INSTABILITY, ¿CRACKLING,¿ AND POSTERIOR KNEE / CALF MASS. SIGNS INCLUDE EFFUSION, TTP, STIFFNESS, INSTABILITY. RADIOGRAPHIC FEATURES RANGE FROM COMPLETELY NORMAL TO GROSS POLYETHYLENE THINNING, OSTEOLYSIS, IMPLANT LOOSENING, AND SOFT TISSUE MASS. SURGICAL FINDINGS INCLUDE COMPLETE LOOSENING OF POLYETHYLENE COMPONENT WITH PRISTINE CEMENT MANTLE, SYNOVITIS, OSTEOLYSIS, AND POLYETHYLENE PITTING / DELAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585013 LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 13MM UNK 10885862001825

    Patients

    Seq Age Sex Outcome Treatment
    1