BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILI-C

    MDR report key: 22781308 · Received August 12, 2025

    Report

    Report Number
    3013881076-2025-00003
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    June 6, 2025
    Report Date
    August 11, 2025
    Manufacturer
    CARTIHEAL LTD.
    Product Code
    QRU
    UDI-DI
    07290019087168
    PMA / PMN Number
    P210034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED, AND NO EVIDENCE WAS FOUND TO SUGGEST THAT THE PRODUCT DEVIATED FROM ITS SPECIFICATIONS AT THE TIME OF MANUFACTURE. FOLLOWING THE EVALUATION OF POST-IMPLANTATION MRI IMAGES AND INTRAOPERATIVE ARTHROSCOPIC OBSERVATIONS, THE MANUFACTURER HAS CONCLUDED THAT THE AGILI-C IMPLANTS WERE LIKELY FRACTURED DURING THE POSTOPERATIVE PERIOD. THIS FRACTURE APPEARS TO HAVE RESULTED IN LOOSENING AT THE TOP OF THE IMPLANT, AS EVIDENCED DURING ARTHROSCOPY. IT IS SUSPECTED THAT THE FRACTURE MAY HAVE LED TO THE RELEASE OF LOOSE IMPLANT FRAGMENTS INTO THE JOINT CAVITY. THESE FRAGMENTS COULD HAVE TRIGGERED INTRA-ARTICULAR IRRITATION, THEREBY CONTRIBUTING TO THE DEVELOPMENT OF KNEE SWELLING AND PAIN. IMPLANT FRACTURE IS A KNOWN ADVERSE EVENT AND DOCUMENTED IN THE IFU AND IN THE AGILI-C RISK ANALYSIS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT, A 36-YEAR-OLD FEMALE, WAS IMPLANTED WITH 2 AGILI-C IMPLANTS IN THE MFC OF THE RIGHT KNEE. IN ADDITION, THE PATIENT UNDERWENT A CONCOMITANT MPFL AND AN OCA OF THE PATELLA AT THE TIME OF IMPLANTATION. THE PATIENT HAD REPORTEDLY BEEN DOING VERY WELL FOR THE FIRST 9-10 WEEKS POST IMPLANTATION AND THEN PRESENTED WITH PAIN AND SWELLING. NO ISSUES WERE REPORTED AT THE TIME OF IMPLANTATION AND NO KNOWN TRAUMA POST OPERATIVELY. ON (B)(6) 2025, CARTIHEAL WAS INFORMED THAT THE PATIENT UNDERWENT ARTHROSCOPIC EXPLORATION ON (B)(6) 2025. DURING THAT ARTHROSCOPIC LOOK, THE SURGEON FOUND LOOSE SOFT TISSUE FRAGMENTS AROUND THE IMPLANT, SO SHE PROCEEDED TO REMOVE/DEBRIDE THEM. THE SURGEON ALSO FOUND THAT THE IMPLANTS LOOKED LOOSE; WHEN SHE ATTEMPTED TO REMOVE THE IMPLANTS WITH A PITUITARY-TYPE INSTRUMENT, ONLY THE TOP HALF OF THE IMPLANTS CAME OFF. BASED ON HER SURGICAL EXPERTISE, SHE DECIDED TO LEAVE THE BOTTOM HALF OF THE IMPLANTS BECAUSE THEY DID NOT SEEM LOOSE. THE PATIENT IS DOING BETTER AND IS BEING MONITORED CLOSELY. NO FURTHER INTERVENTION IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349967 AGILI-C AGILI-C QRU CARTIHEAL LTD. AGILI-C 7.5MM 161 07290019087168

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention