BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 13606156 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00007
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    October 3, 2011
    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 NOT RETURNED NOR WERE IMAGES PROVIDED FOR REVIEW; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. THE LOT NUMBER FOR THE IMPLANTED DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUED NOTED. ON (B)(6) 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED NOR WERE IMAGES PROVIDED FOR REVIEW; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. THE LOT NUMBER FOR THE IMPLANTED DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUED NOTED. ON (B)(6) 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

    AFTER INITIAL IMPLANT BONE HARVEST USED TO BACKFILL MTP CAVITY SO IMPLANT COULD BE RAISED AND SEATED 0.5-1.5 MM PROUD.

    Description of Event or Problem · 0

    AFTER INITIAL IMPLANT BONE HARVEST USED TO BACKFILL MTP CAVITY SO IMPLANT COULD BE RAISED AND SEATED 0.5-1.5 MM PROUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389490 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA CAR-10 F031010001

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention