BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILI-C

    MDR report key: 21204131 · Received January 21, 2025

    Report

    Report Number
    3013881076-2025-00001
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    December 20, 2024
    Report Date
    June 5, 2025
    Manufacturer
    CARTIHEAL
    Product Code
    QRU
    UDI-DI
    07290019087168
    PMA / PMN Number
    P210034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. EFFORTS WERE MADE TO OBTAIN FURTHER RELEVANT DETAILS REGARDING THE EVENT; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL, AND NO ADDITIONAL INFORMATION COULD BE RETRIEVED. GIVEN THE LIMITED DATA AVAILABLE FOR ANALYSIS, IT WAS NOT POSSIBLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, WE WILL RE-OPEN THE INVESTIGATION AND SUBMIT A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A 37 Y/O MALE WAS IMPLANTED WITH 2 AGILI-C IMPLANTS IN THE MFC, AT THE (B)(6) CENTER. CONCOMITANTLY, THE PATIENT UNDERWENT BOTH ACL RECONSTRUCTION AND A MENISCAL REPAIR. ON (B)(6) 2024, THE MANUFACTURE WAS NOTIFIED THAT THE PATIENT WAS EXPERIENCING PAIN, SWELLING, AND DIFFICULTY WITH DAILY ACTIVITIES, WHICH MAY REQUIRE REVISION SURGERY. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. THE 2 AGILI-C IMPLANTS WERE REPLACED WITH TWO OSTEOCHONDRAL ALLOGRAFTS (OCA) IN A SNOWMAN TECHNIQUE. IN ADDITION, THE PATIENT UNDERWENT A CONCOMITANT MENISCECTOMY.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A 37 Y/O MALE WAS IMPLANTED WITH 2 AGILI-C IMPLANTS IN THE MFC. CONCOMITANTLY, THE PATIENT UNDERWENT BOTH ACL RECONSTRUCTION AND A MENISCAL REPAIR. ON SEPTEMBER 17, 2024, THE MANUFACTURE WAS NOTIFIED THAT THE PATIENT WAS EXPERIENCING PAIN, SWELLING, AND DIFFICULTY WITH DAILY ACTIVITIES, WHICH MAY REQUIRE REVISION SURGERY. ON DECEMBER 23, 2024, IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024. THE 2 AGILI-C IMPLANTS WERE REPLACED WITH TWO OSTEOCHONDRAL ALLOGRAFTS (OCA) IN A SNOWMAN TECHNIQUE. IN ADDITION, THE PATIENT UNDERWENT A CONCOMITANT MENISCECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590668 AGILI-C AGILI-C QRU CARTIHEAL AGILI-C 7.5MM 144 07290019087168

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention| H