BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTIVA

    MDR report key: 13606028 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    January 29, 2009
    Report Date
    January 4, 2021
    Manufacturer
    CARTIVA
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    IMPLANT OBSERVED TO BE FRACTIONALLY BELOW THE BONE SURFACE INSTEAD OF REMAINING PROUD OF THE BONE SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436862 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA CAR-08 060308004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other