BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTIVA

    MDR report key: 13606401 · Received February 25, 2022

    Report

    Report Number
    3009351194-2022-00014
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    May 5, 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. THE ARTICULATING SURFACE HAD SHARP BLADE CUTS AND UNIDIRECTIONAL SCUFFING. THE CUTS LIKELY OCCURRED AT IMPLANT REMOVAL. WHILE UNCONFIRMED, THE SCUFFING IS NOT INCONSISTENT WITH THE SCUFFING OBSERVED ON THE CARTIVA IN THE CARTILAGE WEAR STUDY WHICH SIMULATED THE EQUIVALENT OF 5 YEARS OF AGGRESSIVE USE. 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

    EXPLANT OF DEVICE AND REPLACED WITH ANOTHER CAR-10 IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390532 CARTIVA PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PNW CARTIVA CAR-10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other