BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 2

    MDR report key: 21506430 · Received March 3, 2025

    Report

    Report Number
    1038671-2025-01363
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    March 7, 2023
    Report Date
    March 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001122
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND TIBIAL TRAY SUBSIDENCE AS STATED IN THE OPERATIVE NOTES. THE PROSTHESIS WEAR MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE AND/OR PATIENT-RELATED CONDITIONS. THE TIBIAL TRAY SUBSIDENCE MAY HAVE BEEN THE RESULT OF POOR BONE QUALITY, MISALIGNMENT, A LOAD TRANSFER ISSUE, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THE REASON FOR THE REPORTED PROSTHESIS WEAR, FEMORAL LOOSENING, AND TIBIAL TRAY SUBSIDENCE COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES/RADIOGRAPHS WERE UNABLE TO BE OBTAINED. H6: CORRECTED INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: (2886092) 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM;P (4010919) 200-02-32 - THREE PEG PATELLA 32MM; (3933347) 02-012-41-2020 - LOGIC TIBIA TRAPTRAY CEM SZ 2F/2T. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND JOINT LAXITY. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING CEMENTED LEFT KNEE PROSTHESIS AND POLYETHYLENE WEAR/FAILURE. INTRAOPERATIVE FINDINGS NOTED SYNOVITIS WITH PE PARTICLES. SIGNIFICANTLY LOOSE CEMENTED PS FEMORAL COMPONENT. SUBSIDED CEMENTED TIBIAL COMPONENT. WORN PE PATELLA COMPONENT-WELL FIXED. MEDIAL CAVITARY DISTAL FEMORAL BONE LOSS WAS NOTED. NO SIGNIFICANT TIBIAL OR PATELLA BONE LOSS WAS ENCOUNTERED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345328 LOGIC FEMORAL PS CEM LEFT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001122

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R