BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 11769193 · Received May 4, 2021

    Report

    Report Number
    3009351194-2021-00113
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    August 10, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTED DATA IN D9. THE REPORTED EVENT COULD BE CONFIRMED, SINCE IMAGES PROVIDED INDICATE REMOVAL OF THE IMPLANT DUE TO PAIN. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT FACTORS RELATED ISSUE. THE FAILURE WAS CAUSED BY PAIN AND CYSTIC CHANGES IN THE PATIENT'S FIRST METATARSAL BONE. THERE ARE MANY CLINICAL FACTORS THAT CAN AFFECT THE RESULTS OF ANY SURGERY, SUCH AS SURGICAL TECHNIQUE, PRE-OPERATIVE AND POST-OPERATIVE CARE, THE IMPLANT, PATIENT PATHOLOGY AND DAILY ACTIVITY. THE CURRENT PACKAGE INSERT PROVIDED WITH THESE DEVICES STATES, "AN IMPLANT SITE MAY BECOME INFECTED, PAINFUL, SWOLLEN, OR INFLAMED. RISKS ASSOCIATED WITH IMPLANTATION OF HEMI-ARTHROPLASTY DEVICES OR CARTIVA SYNTHETIC CARTILAGE IMPLANT INCLUDE BONY REACTION, IMPLANT LOOSENING, IMPLANT DISLOCATION/DISLODGEMENT, CYSTS, BONY EROSION, AND DEVICE WEAR." THE DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 2.5 YEARS. OUR MEDICAL PROFESSIONAL CONFIRMED THERE ARE CLEAR SIGNS OF CYSTIC CHANGES IN THE FIRST METATARSAL BONE, WHICH WAS ALSO CONFIRMED DURING THE REVISION SURGERY. WHILE THIS IS A KNOWN ADVERSE EVENT AFTER CARTIVA IMPLANTATION, THE ROOT CAUSE IS NOT ENTIRELY CLEAR. SOME REPORTS RELATE THIS ADVERSE EVENT TO BIOCOMPATIBILITY ISSUES, AN INFLAMMATORY REACTION IN THE BODY MOST PROBABLY CAUSED BY THE MATERIAL. WHETHER THAT WAS THE CASE FOR THIS PATIENT CAN ONLY BE CONFIRMED BY THE PATHOLOGIST CHECKING OF THE TISSUES/ BONE WHICH MAY HAVE BEEN REMOVED AND SEND FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD CONTINUAL PAIN AT THE FIRST MTP JOINT AND UNDERWENT A REVISION SURGERY TO REMOVE THE TOE IMPLANT. DURING THE REVISION IT WAS FOUND THAT THE IMPLANT HAD SIGNIFICANT WEAR ON THE ARTICULATING SURFACE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LARGE CYST FORMED BENEATH THE IMPLANT. IN THE REVISION SURGERY, THE SURGEON USED BONE GRAFT TO FILL THE VOID AND INSERTED A MTP PLATE WITH SCREWS FOR ARTHRODESIS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD CONTINUAL PAIN AT THE FIRST MTP JOINT AND UNDERWENT A REVISION SURGERY TO REMOVE THE TOE IMPLANT. DURING THE REVISION IT WAS FOUND THAT THE IMPLANT HAD SIGNIFICANT WEAR ON THE ARTICULATING SURFACE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LARGE CYST FORMED BENEATH THE IMPLANT. IN THE REVISION SURGERY, THE SURGEON USED BONE GRAFT TO FILL THE VOID AND INSERTED A MTP PLATE WITH SCREWS FOR ARTHRODESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669192 CARTIVA PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention