BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA DEVICE 10MM T20-0388

    MDR report key: 23875448 · Received December 23, 2025

    Report

    Report Number
    3009351194-2025-00220
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    May 21, 2025
    Report Date
    February 25, 2026
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    UDI-DI
    00852897002182
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE CURRENTLY DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A "PERSONAL INJURY CLAIM ARISING OUT OF SURGERY WHICH PATIENT ALLEGES UNDERWENT ON (B)(6) 2022, PERFORMED BY DR (B)(6), ORTHOPAEDIC SURGEON AT (B)(6) HOSPITAL, SOUTH AUSTRALIA. PATIENT CLAIM ALLEGES THE FOLLOWING: "THE SURGERY INVOLVED IMPLANTATION OF A 1ST MTPJ CARTIVA IMPLANT, OSTECTOMY AND GASTROCNEMIUS RELEASE. FOLLOWING THE SURGERY, OUR CLIENT SUFFERED FROM ONGOING SWELLING AND PAIN AT THE SITE OF THE OPERATION, RESULTING IN ONGOING CALF PAIN AND CAUSING HER TO WALK WITH AN ANTALGIC GAIT. DR (B)(6) RECOMMENDED FURTHER SURGERY TO REMOVE THE IMPLANT, WITH BONE GRAFTING AND A 1ST MTPJ FUSION AND THIS WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2025."

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A "PERSONAL INJURY CLAIM ARISING OUT OF SURGERY WHICH PATIENT ALLEGES UNDERWENT ON (B)(6) 2022, PERFORMED BY DR. (B)(6), ORTHOPAEDIC SURGEON AT (B)(6). PATIENT CLAIM ALLEGES THE FOLLOWING: "THE SURGERY INVOLVED IMPLANTATION OF A 1ST MTPJ CARTIVA IMPLANT, OSTECTOMY AND GASTROCNEMIUS RELEASE. FOLLOWING THE SURGERY, OUR CLIENT SUFFERED FROM ONGOING SWELLING AND PAIN AT THE SITE OF THE OPERATION, RESULTING IN ONGOING CALF PAIN AND CAUSING HER TO WALK WITH AN ANTALGIC GAIT. DR. (B)(6) RECOMMENDED FURTHER SURGERY TO REMOVE THE IMPLANT, WITH BONE GRAFTING AND A 1ST MTPJ FUSION AND THIS WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2025."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703203 CARTIVA DEVICE 10MM T20-0388 PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC F060321001 00852897002182

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention