BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILI-C

    MDR report key: 20260989 · Received September 19, 2024

    Report

    Report Number
    3013881076-2024-00002
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 19, 2024
    Manufacturer
    CARTIHEAL LTD.
    Product Code
    QRU
    UDI-DI
    07290019087182
    PMA / PMN Number
    P210034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF PRODUCTION RECORDS FOUND NO ISSUES ASSOCIATED WITH THE LOT/SN. IT IS THE MANUFACTURER'S ASSESSMENT THAT DUE TO THE PROUD POSITIONING OF THE IMPLANT, ONCE THE PATIENT RETURNED TO DAILY ACTIVITIES AND REGAINED FULL WEIGHT BEARING, THE IMPLANT WAS EXPOSED TO THE WEIGHT BEARING FORCES WHICH MIGHT HAVE LED TO MICROMOVEMENTS, RESULTING IN IMPLANT LOOSENING. IMPLANT LOOSENING DUE TO IMPLANT PROTRUSION IS A KNOWN RISK.

    Description of Event or Problem · 0

    PATIENT WAS TREATED AT (B)(6) 2024 WITH FIVE AGILI-C 7.5MM IMPLANTS. 4 IMPLANTS IN THE TROCHLEA AND 1 IMPLANT IN THE MFC (MEDIAL FEMORAL CONDYLE). POST-OP KNEE X-RAYS INDICATED THAT MFC IMPLANT WAS PROTRUDING AND NOT FULLY RECESSED BELOW THE ARTICULAR CARTILAGE TO THE LEVEL OF THE SUBCHONDRAL BONE AS INSTRUCTED BY THE IFU. ON (B)(6) 2024, THE PATIENT UNDERWENT ARTHROSCOPY DUE TO POST-OPERATIVE RECURRING EFFUSION OF THE KNEE. THE MFC IMPLANT WAS REMOVED DUE TO IMPLANT LOOSENING. NO ADDITIONAL INFORMATION IS EXPECTED. FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329639 AGILI-C AGILI-C QRU CARTIHEAL LTD. AGILI-C 7.5MM 144 07290019087182

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Other