BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA SCI IMPLANT FOR MTP

    MDR report key: 13606479 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00072
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    August 14, 2018
    Report Date
    August 6, 2018
    Manufacturer
    CARTIVA, INC
    Product Code
    PNW
    PMA / PMN Number
    P150017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTION OR IS RELATED TO A DEATH OR INJURY. 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

    ACCORDING TO THE INFORMATION RECEIVED FROM THE PATIENT, SHE RECEIVED THE CARTIVA SCI IMPLANT ON (B)(6) 2017 WITHOUT INCIDENT. AFTER INITIAL SURGERY , THE PATIENT REPORTED CONTINUED PAIN STARTING APPROXIMATELY 6 MONTHS POST OPERATIVELY. THE PATIENT REPORTED THAT SHE UNDERWENT REVISION TO FUSION ON (B)(6) 2018 AT THE ROSE AND EERIE COMMUNITY MEDICAL CENTER (APPROXIMATELY 14 MONTHS POST INITIAL PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680615 CARTIVA SCI IMPLANT FOR MTP METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS, PNW CARTIVA, INC 10 MM F0302117001

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention