BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK THREE PEG PATELLA 38MM

    MDR report key: 20844137 · Received December 4, 2024

    Report

    Report Number
    1038671-2024-04618
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    March 19, 2024
    Report Date
    December 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED FOR EVALUATION; THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS AND RADIOGRAPH IMAGES OF THE DEVICE. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF FEMORAL LOOSENING, PROSTHESIS WEAR, AND OSTEOLYSIS. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE. THE POLYETHYLENE WEAR MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, INSTABILITY, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. CONCOMITANTS: 4004267 - 02-010-04-0240 - LOGIC CR FEMORAL POR, LEFT, SZ 4, 4311553 - 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T, 3848695 - 02-012-47-4009 - LOGIC CR TIB INSERT STD, SZ 4, 9MM, 4010787 - 200-02-38 - THREE PEG PATELLA 38MM. 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

    APPROXIMATELY 7 YEARS 9 MONTHS POST THE INITIAL LEFT KNEE IMPLANTATION, IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING, OSTEOLYSIS AND POLY WEAR. ALL COMPONENTS WERE REMOVED AND WERE REPLACED BY A COMPETITOR¿S REVISION KNEE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THEY WERE DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839248 OPTETRAK THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization SEE H11