BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILI-C 7.5MM

    MDR report key: 23156476 · Received September 26, 2025

    Report

    Report Number
    3013881076-2025-00004
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 21, 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 DEVICE BATCH HISTORY RECORDS WAS CONDUCTED, AND NO EVIDENCE WAS FOUND TO SUGGEST THAT THE PRODUCT DEVIATED FROM ITS SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF THE RISK FILES HAS CONFIRMED THAT THE FAILURE MODE AND ASSOCIATED RISKS HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THAT THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. NO NEW HARM WAS IDENTIFIED IN THIS EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A KNEE SURGERY PERFORMED HAD BEEN PERFORMED ON (B)(6) 2024 TO PLACE SIX (6) AGILI-C IMPLANTS, THE PATIENT WAS FEELING PERSISTENT PAIN, PARTICULARLY IN THE MEDIAL FEMORAL CONDYLE. THE PATIENT WAS SCOPED ON (B)(6) 2025 AND IT WAS NOTICED THAT (I) THE TWO (2) PLUGS IN THE MEDIAL FEMORAL CONDYLE DID NOT INCORPORATE INTO THE BONE; (II) ONE (1) PLUG IN THE TROCHLEA WAS PARTIALLY INCORPORATED WHILE THE OTHER WAS FULLY INCORPORATED; AND (III) BOTH (2) PLUGS IN THE LATERAL FEMORAL CONDYLE INCORPORATED PHENOMENALLY. THE AFFLICTED TROCHLEA AND MEDIAL FEMORAL CONDYLE WERE REMEDIATED WITH ARTHROSURFACE METAL REFACING IMPLANTS. THE PATIENT HAS DOING FINE AFTERWARDS, ALTHOUGH WITH SOME DISCOMFORT SIMILAR TO PAIN LEVEL BEFORE SURGERY. THE PHYSICIAN CANNOT POINT TO A PARTICULAR PROBLEM OR EVENT THAT RESULTED IN THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279227 AGILI-C 7.5MM IMPLANT, RESORBABLE, FOR ARTICULAR OSTEOCHONDRAL REPAIR QRU CARTIHEAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention