BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 10453961 · Received August 26, 2020

    Report

    Report Number
    3009351194-2020-00011
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    October 10, 2017
    Report Date
    July 30, 2020
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED NOR WERE IMAGES PROVIDED FOR REVIEW; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE LEFT TOE. THE PATIENT REPORTS HAVING PAIN AND STIFFNESS FOLLOWING THE PROCEDURE. THE PATIENT STATES, " I HAD VARIOUS POST CHECKS WITH PHYSICIANS ASSISTANTS WHO SAID THIS WAS NORMAL AND TO BE PATIENT. SHE ORDERED PHYSICAL THERAPY FOR THE NEW TROUBLESOME PROBLEMS I WAS HAVING WITH MY L TOE. SHE GAVE ME AN RX PIECE OF PAPER FOR PT. I WHEELED ON MY KNEE SCOOTER, OUT TO MY CAR AND SAT TO CAREFULLY READ THE PT PRESCRIPTION. THERE HAND WRITTEN WAS "L TOE CARTIVA IMPLANT". I WAS CONFUSED, SO I LOOKED UP CARTIVA ON MY PHONE AND LEARNED THE CARTIVA WAS A BRAND NEW IMPLANT, STILL UNDERGOING CLINICAL TRIALS IN THE US AND CONSIDERED EXPERIMENTAL IN OTHER COUNTRIES. I CONTINUED READING CARTIVA'S WEB PAGE: IF YOU ARE CONSIDERING CARTIVA, TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING WHICH COULD HURT IMPLANT SUCCESS. YOU HAVE HAD CANCER. I HAVE . YOU HAVE HAD CHEMOTHERAPY. I HAVE, A LOT. YOU HAVE TAKEN STEROIDS. I HAVE. YOU HAVE POOR BONE QUALITY. I HAVE OSTEOPENIA POST CHEMO. HERE, SITTING IN MY CAR, I DEVELOPED A SICKENING SENSE OF BETRAYAL. WHY DIDN'T DR. AMINIAN TELL ME ABOUT THE CARTIVA? I WAS DUMBFOUNDED. IN HINDSIGHT, I WAS IN A STATE OF SHOCK, NUMB. I NEVER GAVE AUTHORIZATION FOR A CARTIVA. MY PRE-OP CONSULTS WERE DECEPTIVE. FURTHERMORE, HE DIDN'T RESEARCH THE EXCLUSION CRITERIA FOR CARTIVA. I WAS NOT A VIABLE CARTIVA CANDIDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922018 CARTIVA PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention