BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 13606410 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00024
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    April 30, 2018
    Report Date
    January 7, 2021
    Manufacturer
    CARTIVA
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR REVIEW. THE HEIGHT OF THE DEVICE AND DIAMETER WERE WITHIN THE POST-STERILIZATION VALUE RANGE. VISUAL EXAMINATION FOUND ON THE ARTICULAR SURFACE SUCFFING, A SMOOTH CUT AS FROM A SCALPEL BLADE, AND A ROUGH DEPRESSION ON THE RADIUSED EDGE OF THE ARTICULATING SURFACE. THE DEPRESSION APPROXIMATED THE SHAPE OF THE 2MM GUIDE PIN PROVIDED WITH THE CARTIVA INSTRUMENTATION. THE SCUFFING IS CONSISTENT WITH SCUFFING OBSERVED IN THE CARTIVA ON CARTILAGE WEAR STUDY. MORE DETAIL IS AVAILABLE ON 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

    EXPLANT PERFORMED ON UNIDENTIFIED PATENT AFTER TWO YEARS IMPLANTED. NO FURTHER DETAILS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390534 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA CAR-10 F021116002

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other