BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILI-C

    MDR report key: 15906302 · Received December 2, 2022

    Report

    Report Number
    3013881076-2022-00001
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 3, 2022
    Report Date
    August 22, 2023
    Manufacturer
    CARTIHEAL LTD.,
    Product Code
    QRU
    UDI-DI
    07290019087021
    PMA / PMN Number
    P210034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF PRODUCTION RECORDS FOUND NO ISSUES ASSOCIATED WITH THE LOT OR SERIAL NUMBER. LACK OF IMPLANT INTEGRATION AND BONE CYSTS ARE KNOWN ADVERSE EVENTS, AS DOCUMENTED IN THE AGILI-C IFU AND RISK ANALYSIS.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF PRODUCTION RECORDS FOUND NO ISSUES ASSOCIATED WITH THE LOT OR SERIAL NUMBER. LACK OF IMPLANT INTEGRATION AND BONE CYSTS ARE KNOWN ADVERSE EVENTS, AS DOCUMENTED IN THE AGILI-C IFU AND RISK ANALYSIS.

    Description of Event or Problem · 0

    SUBJECT (B)(4), AS PART OF A CLINICAL STUDY WAS IMPLANTED WITH 2 AGILI-C IMPLANTS ON (B)(6) 2018. AN ARTHROSCOPY WAS PERFORMED ON (B)(6) 2022, FOLLOWING SEVERAL MONTHS OF KNEE PAIN WHICH DID NOT RESOLVE WITH CONSERVATIVE TREATMENT. DURING THE PROCEDURE, ONE OF THE AGILI-C IMPLANTS WAS EXTRACTED DUE TO LACK OF IMPLANT INTEGRATION AND CYST FORMATION. THE BONE CYST WAS FILLED AND IMPACTED WITH ALLOGRAFT BONE CHIPS WITH BMCA. CONCOMITANTLY, THE SUBJECT UNDERWENT MEDIAL MENISCECTOMY DUE TO AN UNRELATED DEGENERATIVE MENISCAL TEAR.

    Description of Event or Problem · 0

    SUBJECT (B)(6), AS PART OF A CLINICAL STUDY WAS IMPLANTED WITH 2 AGILI-C IMPLANTS ON (B)(6) 2018. AN ARTHROSCOPY WAS PERFORMED ON (B)(6) 2022, FOLLOWING SEVERAL MONTHS OF KNEE PAIN WHICH DID NOT RESOLVE WITH CONSERVATIVE TREATMENT. DURING THE PROCEDURE, ONE OF THE AGILI-C IMPLANTS WAS EXTRACTED DUE TO LACK OF IMPLANT INTEGRATION AND CYST FORMATION. THE BONE CYST WAS FILLED AND IMPACTED WITH ALLOGRAFT BONE CHIPS WITH BMCA. CONCOMITANTLY, THE SUBJECT UNDERWENT MEDIAL MENISCECTOMY DUE TO AN UNRELATED DEGENERATIVE MENISCAL TEAR. FOLLOWING THE SUBJECTS VISIT ON (B)(6)2023, IT WAS REPORTED THAT THE EVENT WAS CLOSED AS THE SUBJECT RECOVERED. NO ADDITIONAL INFORMATION IS EXPECTED. FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557851 AGILI-C AGILI-C QRU CARTIHEAL LTD., AGILI-C 12.5MM 127 07290019087021
    542475 AGILI-C AGILI-C QRU CARTIHEAL LTD., AGILI-C 12.5MM 127 07290019087021

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other