BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 13606471 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00032
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    November 20, 2018
    Report Date
    January 15, 2021
    Manufacturer
    CARTIVA
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR REVIEW. MORE DETAILS CAN BE FOUND IN THE ATTACHED REPORT. ON NOVEMBER 10TH, 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

    SURGEON CONTACTED THE SALES REP REQUESTING INFORMATION AND MEDICAL ADVICE CONCERNING A FEMALE PATIENT THAT APPEARED TO HAVE DEVELOPED A GANGLION CYST ON HER MTP JOINT FOLLOWING A CARTIVA IMPLANT PROCEDURE ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390535 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA CAR-08 F040617001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other