BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTIVA SCI IMPLANT FOR MTP

    MDR report key: 13606253 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00073
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    April 6, 2017
    Report Date
    December 5, 2017
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTION OR IS RELATED TO A DEATH OR INJURY. MEDWATCH SUBMITTED : (B)(4). ON (B)(6) 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

    MEDWATCH REPORT RECEIVED STATED IN EVENT DESCRIPTION: "HAD A SURGERY FOR HALLUX RIGIDUS OF MY BIG LEFT TOE WITH A CARTIVA IMPLANT PUT IN MTP JOINT. IT WAS A FAILED SURGERY AND THE IMPLANT IS NOT IN PLACE. X­ RAYS PROVED THE IMPLANT SUBSIDED AND ISN'T IN THE PROPER PLACE, LEAVING ME WITH BONE ON BONE. THEN I DEVELOPED CRPS. THE DAY OF THE SURGERY WAS (B)(6) 2017. I COULD NOT ACCUMULATE FROM DAY ONE. IT WAS SUPPOSE TO BE EASY BACK TO WORK IN 2 WEEKS. WELL, NOT MY STORY I COULDN'T WALK WITHOUT CRUTCHES WALKER, SEVERE PAIN, REDNESS, SWELLING. MY SURGEON STATED IT WAS A FAILED SURGERY ABOUT 7 WEEKS AFTER, I HAD RETROGRESSED AND STILL IN SEVERE PAIN. THE X-RAYS CONFIRMED THE CARTIVA IMPLANT WASN'T IN THE PACER. IT WAS SUPPOSE TO BE LEAVING ME WITH BONE ON BONE AND THE CONDITION CHRONIC REGIONAL PAIN SYNDROME (CRPS). THIS CONDITION LEAVES ME WITH NO OPTION FOR SURGERY TO CORRECT THIS ISSUE. THE RISK IS THE CRPS SPREADING TO OTHER PARTS OF MY BODY (NERVE DAMAGE) THE CARTIVA REMAINS IN MY FOOT JUST NOT IN PLACE. DEVELOPED HYPERTENSION AFTER SURGERY, GAD, DEVELOPED CRPS AFTER THE SURGERY. PTSD AFTER SURGERY."REFER TO MEDWATCH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435805 CARTIVA SCI IMPLANT FOR MTP METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS, PNW CARTIVA, INC 10 MM F010517002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability