BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 4

    MDR report key: 21104517 · Received January 8, 2025

    Report

    Report Number
    1038671-2025-00153
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 18, 2021
    Report Date
    March 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001252
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE DISREGARD THIS REPORT AS IT WAS REPORTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT #1038671-2021-00741.

    Additional Manufacturer Narrative · 0

    D10: 4312114 02-012-44-4009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM, 5671484 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F/4T, 4784011 200-02-35 - THREE PEG PATELLA 35MM, 315620 203-96-01 - SAW BLADE NEW STRYK .050 - 11-2222, 264318 203-96-03 - SAW BLADE NEW STRYKER .050 - 11-2216. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2021-00741. 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 30 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, CHRONIC PROGRESSIVE PAIN, INCREASING ONGOING SWELLING, FREQUENT CLICKING AND GRINDING, OCCASIONAL LOCKING AND GIVING OUT OF THE KNEE, WORSENING PAIN WITH ACTIVITY, TWISTING OR CHANGING DIRECTION, ARISING FROM A SITTING TO STANDING POSITION, AND GOING UP OR DOWN THE STAIRS, DIFFICULTY WALKING AND BENDING, AND INCREASING DIFFICULTY PERFORMING ACTIVITIES OF DAILY LIVING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036229 LOGIC FEMORAL PS CEM RIGHT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11.