BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 3

    MDR report key: 25143162 · Received May 11, 2026

    Report

    Report Number
    1038671-2026-00574
    Event Type
    Injury
    Date Received
    May 11, 2026
    Report Date
    May 11, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001146
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED. THE PATIENT HAD DONE WELL, BUT DEVELOPED PAIN, SWELLING, AND 'CRACKLING' IN THEIR KNEE. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. SUMMARY OF PRESENTATION OF 5 PATIENTS: (ADD THIS TO ALL CASES ABOVE) 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
    232305 LOGIC FEMORAL PS CEM LEFT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001146

    Patients

    Seq Age Sex Outcome Treatment
    1