BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA IMPLANT

    MDR report key: 13606081 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00066
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    January 24, 2019
    Report Date
    November 25, 2019
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. ON NOVEMBER 10, 2020 STRYKER TRAUMA AND EXTREMITIES ACQUIRED CARTIVA, WRIGHT MEDICAL, TORNIER INC. AND TORNIER SAS. AN EFFORT WAS MADE TO ALIGN THE ACQUIRED ENTITY COMPLAINT FILES WITH STRYKER'S POLICIES AND PROCEDURES. STRYKER HAS PERFORMED RETROSPECTIVE REVIEW OF COMPLAINTS AND THE REPORTABILITY DECISION WAS REVISED TO REPORT THIS INCIDENT UNDER THE MDR/VIGILANCE PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. IT WAS REPORTED ON MEDWATCH MW5090909 BY THAT PATIENT THAT, "I HAD BILATERAL CARTIVA IMPLANTS PLACED IN GREAT TOES BILATERALLY AND BONE SPURS REMOVED ON (B)(6) 2019. I WENT THROUGH PHYSICAL THERAPY AFTER MY SURGERY. I WAS STILL HAVING PAIN IN MY GREAT TOE JOINTS AFTER RETURNING TO WORK AFTER SURGERY, BUT WAS TOLD MAY TAKE 6 MONTHS TO HEAL. THE PAIN IN MY GREAT TOE JOINTS SEEMED TO BE GETTING WORSE AND NOT BETTER. I TALKED WITH MY DR ABOUT THIS AND FOLLOWED UP IN HIS OFFICE ON (B)(6) 2019. X-RAYS WERE DONE AND FOUND THAT THE CARTIVA IMPLANTS HAD FAILED AND I NO LONGER HAD ANY SPACE IN THE JOINT. I WAS TOLD THAT I WILL NEED TO HAVE THE CARTIVA IMPLANTS REMOVED AND DIFFERENT IMPLANTS INSERTED. I AM A NURSE WHO WORKS FULL TIME AND ON MY FEET CONSTANTLY FOR 9 HOUR SHIFTS AT A TIME. I HAVE SIGNIFICANT PAIN EVERY DAY. I AM HAVING SURGERY ON (B)(6) 2019 TO HAVE THE CARTIVA REMOVED. I WOULD HAVE THE SURGERY SOONER BUT IT IS A VERY BUSY TIME AT WORK. I WORK IN OUTPATIENT SURGERY AND I AM WAITING TO TAKE OFF WORK AFTER THE HOLIDAYS AND TO BUILD MY TIME­OFF BACK UP SINCE I WAS OFF FOR 6 WEEKS AFTER THE FIRST SURGERY. HAD TO HAVE ANOTHER SURGERY. AFTER HAVING CARTIVA IMPLANTS PLACED, I HAVEN'T BEEN ABLE TO RUN ANYMORE BECAUSE MY FEET ARE TOO UNCOMFORTABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399640 CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention