BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILI-C

    MDR report key: 21543096 · Received March 6, 2025

    Report

    Report Number
    3013881076-2025-00002
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    January 3, 2025
    Report Date
    March 6, 2025
    Manufacturer
    CARTIHEAL LTD.
    Product Code
    QRU
    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 INSTRUCTIONS FOR USE DOCUMENTS FOR THE AGILI-C IMPLANT AND THE RISK ANALYSIS REVEALED THAT IMPLANT LACK OF INTEGRATION HAS BEEN IDENTIFIED AS A KNOWN POTENTIAL COMPLICATION. DEVICE HISTORY RECORD REVIEW AND WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE PATIENT, A 36 YEAR OLD FEMALE, WAS IMPLANTED WITH 1 AGILI-C IMPLANT. THE PATIENT REPORTED CONTINUING KNEE PAIN DURING THE FU POST OPERATIVE PERIOUD, BUT IT WAS NOTED THAT SHE ALSO SUFFERED FROM COMPLEX REGIONAL PAIN SYNDROME (CRPS). THE PHYSICIAN FOLLOWED THE PATIENT CLOSELY AND ORDERED APPROPRIATE FOLLOW UP ULTIMATELY LEADING TO AN MRI WHICH INDICATED NON INTEGRATION OF THE IMPLANT IN THE SUBCHONDRAL BONE. ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE CARTIHEAL IMPLANT AND WAS TREATED WITH AN OCA. INTRAOPERATIVE FINDINGS DEMONSTRATED CARTILAGE FORMATION FROM THE IMPLANT PERIPHERY BUT NO INTEGRATION SUBCHONDRAL LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438008 AGILI-C AGILI-C QRU CARTIHEAL LTD. AGILI-C 7.5MM 144

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention