BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 5

    MDR report key: 20738572 · Received November 20, 2024

    Report

    Report Number
    1038671-2024-04456
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    May 22, 2023
    Report Date
    November 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001269
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 3962002 02-012-44-5009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM 4047566 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 4187043 200-02-35 - THREE PEG PATELLA 35MM MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: (B)(4). 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 VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 90 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT IN THE KNEE WITH SWELLING. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: FAILED TOTAL KNEE ARTHROPLASTY, RIGHT. FINDINGS: THERE WAS SIGNIFICANT FLUID AND SYNOVITIS THROUGHOUT THE JOINT. THERE WAS SOME QUESTIONABLE LOOSENING FROM THE SUPERIOR FLANGE. IT WAS EASILY DEBONDING THE FEMORAL COMPONENT FROM THE CEMENT WAS EASILY DONE. BEHIND THIS, THERE WAS A SIGNIFICANT CYST IN THE LATERAL FEMORAL CONDYLE. DESCRIPTION OF PROCEDURE: FLUID WAS EXPRESSED. AFTER REMOVING ALL THE FLUID, THERE WAS SIGNIFICANT SYNOVITIS, AND EXTENSIVE DEBRIDEMENT WAS PERFORMED EXTERNALLY AND INTERNALLY. THE TIBIA WAS REMOVED. THERE WAS SIGNIFICANT POSTERIOR WEAR OF THE POLY WITH SOME DELAMINATION AT THE VERY POSTERIOR CORNER, ESPECIALLY LATERALLY. WE THEN BEGAN EVALUATING THE FEMORAL COMPONENT. WE WERE CONCERNED THERE WAS SOME LOOSENING AND INDEED IT WAS EASILY ABLE TO BE REMOVED WITH OSTEOTOMES DEBONDING FROM THE CEMENT. WE ALSO NOTED THERE WAS A LARGE CYST, MARBLE SIZE OF THE LATERAL FEMORAL CONDYLE. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO OTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN GOOD CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467778 LOGIC FEMORAL PS CEM RIGHT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001269

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R