BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILI-C

    MDR report key: 18456295 · Received January 5, 2024

    Report

    Report Number
    3013881076-2024-00001
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    October 3, 2023
    Report Date
    January 4, 2024
    Manufacturer
    CARTIHEAL LTD.
    Product Code
    QRU
    UDI-DI
    07290019087021
    PMA / PMN Number
    P210034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SUBJECT (B)(6), AS PART OF A CLINICAL STUDY WAS IMPLANTED WITH 1 AGILI-C IMPLANT IN THE LATERAL FEMORAL CONDYLE ON (B)(6) 2018. ON (B)(6) 2023, THE SUBJECT UNDERWENT TOTAL KNEE REPLACEMENT OF THE LEFT KNEE (INDEX KNEE) DUE TO CONTINUED ANTERO-MEDIAL KNEE PAIN WHICH DID NOT RESPOND TO CONSERVATIVE TREATMENT, RADIO FREQUENCY ABLATION OR HA INJECTIONS. THE EVENT WAS ASSESSED AS "UNLIKELY RELATED (TO STUDY DEVICE AND/OR TOOL-SET OR TO STUDY PROCEDURE)" BY THE TREATING PHYSICIAN (INVESTIGATOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600269 AGILI-C AGILI-C QRU CARTIHEAL LTD. AGILI-C 7.5MM 125 07290019087021

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other