BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WRIGHT CARTIVA IMPLANT

    MDR report key: 14322563 · Received May 7, 2022

    Report

    Report Number
    3009351194-2022-00103
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    December 5, 2017
    Report Date
    October 31, 2024
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS NOT AVAILABLE AS IT IS THE SUBJECT OF A LEGAL MATTER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THIS CASE HAS BEEN COMPLETED, AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT 1ST METATARSAL JOINT CHEILECTOMY WITH A CARTIVA 10 X 10 IMPLANT. IT IS FURTHER ALLEGED THAT THREE MONTHS LATER, A POST OPERATIVE CT SCAN REVEALED ARTHROFIBROSIS WITH IMPINGEMENT OF THE 1ST METATARSOPHALANGEAL JOINT AND ON (B)(6) 2017, HE UNDERWENT A REVISION CHEILECTOMY. IT IS ALLEGED THAT DURING THIS SURGERY THE CARTIVA WAS NOTED TO BE FLUSH WITH THE MTP JOINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT 1ST METATARSAL JOINT CHEILECTOMY WITH A CARTIVA 10 X 10 IMPLANT. IT IS FURTHER ALLEGED THAT THREE MONTHS LATER, A POST OPERATIVE CT SCAN REVEALED ARTHROFIBROSIS WITH IMPINGEMENT OF THE 1ST METATARSOPHALANGEAL JOINT AND ON (B)(6) 2017, HE UNDERWENT A REVISION CHEILECTOMY. IT IS ALLEGED THAT DURING THIS SURGERY THE CARTIVA WAS NOTED TO BE FLUSH WITH THE MTP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376832 UNKNOWN WRIGHT CARTIVA IMPLANT PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H