BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 11918093 · Received June 1, 2021

    Report

    Report Number
    3009351194-2021-00115
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    October 20, 2020
    Report Date
    September 30, 2021
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    UDI-DI
    00852897002038
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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. LIMITED MEDICAL RECORDS WERE PROVIDED AND NO RADIOGRAPHIC IMAGES WERE PRESENTED FOR EVALUATION. FROM THE PROVIDED INFORMATION ON THE PATIENT'S HISTORY, NO CLEAR CONTRA INDICATION WAS APPARENT. THREE YEARS AFTER THE INITIAL SURGERY A REVISION WAS DONE, BECAUSE IT WAS NOTED THE IMPLANT WAS NO LONGER IN PLACE AND RECESSED INTO THE METATARSAL BONE. SINCE THERE IS NO INDICATION IN THE AVAILABLE INFORMATION OF AN APPARENT INFECTION, A CAUSE MAY BE AN INFLAMMATORY REACTION LEADING TO LOOSENING AROUND THE IMPLANT, WHICH IN THE END OF IT ENDING UP IN THE METATARSAL. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE LIMITED AMOUNT OF INFORMATION PROVIDED. THE CURRENT IFU PROVIDED WITH THESE DEVICES DOES LIST THE FOLLOWING AS POTENTIAL ADVERSE EFFECTS, " RISKS ASSOCIATED WITH IMPLANTATION OF HEMI-ARTHROPLASTY DEVICES OR CARTIVA SYNTHETIC CARTILAGE IMPLANT INCLUDE INFECTION, INFLAMMATION, PAIN, SWELLING, EFFUSION, JOINT IRRITATION, FIBROSIS, JOINT INSTABILITY, JOINT MALALIGNMENT, PERIARTICULAR CYST, BONE CYST, BONE LOSS, SESAMOID BONE(S) IRRITATION, SESAMOID BONE(S) FRACTURE, METATARSAL BONE FRACTURE, OSTEONECROSIS, AVASCULAR NECROSIS, IMPLANT FRACTURE, IMPLANT LOOSENING, IMPLANT DISLOCATION, IMPLANT DISLODGEMENT, IMPLANT SUBSIDENCE, REVISION OR CONVERSION TO FUSION, ALLERGIC REACTION TO POLYVINYL ALCOHOL (PVA), PROGRESSIVE OSTEOARTHRITIS (OA), INCORRECT IMPLANT PLACEMENT, AND DAMAGE TO ADJACENT OR SURROUNDING TISSUES. ¿ 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 MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FIRST METATARSOPHALANGEAL JOINT ARTHROPLASTY WITH IMPLANT PLACEMENT TO TREAT HALLUX RIGIDUS ON THE LEFT FOOT. APPROXIMATELY 3 YEAR POST OP THE PATIENT UNDERWENT A REVISION SURGERY. THE IMPLANT HAD RECEDED IN THE BONE AND THE PATIENT HAD CHRONIC PAIN. THE SPACER WAS REMOVED AND THE PATIENT HAD A TITANIUM PLATE AND SCREWS IMPLANTED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. 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 UNDERWENT A FIRST METATARSOPHALANGEAL JOINT ARTHROPLASTY WITH IMPLANT PLACEMENT TO TREAT HALLUX RIGIDUS ON THE LEFT FOOT. APPROXIMATELY 3 YEAR POST OP THE PATIENT UNDERWENT A REVISION SURGERY. THE IMPLANT HAD RECEDED IN THE BONE AND THE PATIENT HAD CHRONIC PAIN. THE SPACER WAS REMOVED AND THE PATIENT HAD A TITANIUM PLATE AND SCREWS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811558 CARTIVA PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC CAR-10-US F101217001 00852897002038

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention