BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 21785283 · Received April 7, 2025

    Report

    Report Number
    1038671-2025-01742
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    November 27, 2023
    Report Date
    April 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6) - 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4, (B)(6) - 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4, (B)(6) - 02-012-35-4009 - LOGIC TIBIA PS MOD INSRT SZ 4 9MM, (B)(6) - 02-012-35-4009 - LOGIC TIBIA PS MOD INSRT SZ 4 9MM, (B)(6) - 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T, (B)(6) - 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T, (B)(6) - 200-02-35 - THREE PEG PATELLA 35MM, (B)(6) - 200-02-35 - THREE PEG PATELLA 35MM. THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND INCLUSION OF THE TIBIAL INSERT IN THE PACKAGING RECALL. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, MAY HAVE LEAD TO LOOSENING AT THE CEMENT-BONE INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POSSIBLE CAUSES FOR POLYETHYLENE DAMAGE INCLUDE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, MALALIGNMENT BETWEEN IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 109 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. LOOSE FEMUR AND RECALLED POLY WERE INDICATED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. NO DEVICE RETURNS ARE ANTICIPATED. DUE TO THE RECALL THE HOSPITAL WILL NOT RELEASE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730844 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H