BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 13606566 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00027
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    October 15, 2018
    Report Date
    January 8, 2021
    Manufacturer
    CARTIVA
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR REVIEW. THE VISUAL EVALUATION FOUND SCRATCHES ON THE LATERAL SURFACE AND TWO PIN HOLES ON THE ARTICULATING SURFACE, THE LATTER LIKELY OCCURRING DURING THE REVISION SURGERY. A SMOOTH DEPRESSION WITH UNIDIRECTIONAL SCUFFING ON ONE SIDE OF THE ARTICULATING SURFACE WAS INCONSISTENT WITH THE SCUFFING OBSERVED IN THE CARTIVA ON CARTILAGE WEAR STUDY WHICH SIMULATED THE EQUIVALENT OF 5 YEARS OF USE WAS FOUND. THE HEIGHT OF THE DEVICE WAS MEASURED AND FOUND TO BE WITHIN THE POST-STERILIZATION VALUE RANGE. THE DEVICE DIAMETER MEASURED SLIGHTLY BELOW THE VALIDATED POST-STERILIZATION VALUES. 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

    THE SURGEON REPORTED THAT THEY SUSPECT IMPLANT SUBSIDENCE ON AN UN-IDENTIFIED PATIENT APPROXIMATELY ONE YEAR POSTOPERATIVELY. THE EXACT DATE OF IMPLANT IS CURRENTLY UNKNOWN. THE SURGEON SUSPECTS THE IMPLANT MAY BE SUBSIDING DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390536 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA CAR-10 F050417001

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other