BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 13606287 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00015
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    June 1, 2017
    Report Date
    January 4, 2021
    Manufacturer
    CARTIVA
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR REVIEW. VISUAL EXAMINATION FOUND SMALL SCRATCHES ON THE LATERAL SURFACES AND THE RADIUSED SHOULDER OF THE IMPLANT. A BLADE CUT EXTENDED FROM THE ARTICULATING SURFACE, CLOSE TO THE PERIMETER, DOWN INTO THE IMPLANT. SCUFFING AND SOME ROUGH TEARS WERE OBSERVED ON THE ARTICULATING SURFACE. THE HEIGHT OF THE DEVICE WAS WITHIN THE POST-STERILIZATION VALUE RANGE. AN EVALUATION OF THE DIAMETER FOUND THE DEVICE TO BE SLIGHTLY BELOW THE VALIDATED POST-STERILIZATION VALUES. BASED ON THE VISUAL AND DIMENSIONAL OBSERVATIONS OF THE RETURNED DEVICE, NO DEFINITIVE CONCLUSION COULD BE DRAWN REGARDING THE REPORTED EVENT. 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 PATIENT UNDERWENT REMOVAL OF THE IMPLANT AND WAS REVISED TO A JOINT FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389494 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA CAR-10 F041613003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other