BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 1520002 · Received October 29, 2009

    Report

    Report Number
    1221934-2009-00443
    Event Type
    Injury
    Date Received
    October 29, 2009
    Date of Event
    November 1, 2008
    Report Date
    October 28, 2009
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANCHORS WHICH WERE REPORTED TO BE DEPUY MITEK SUPER QUICK ANCHORS WILL NOT BE RETURNED FOR EVALUATION AND ROOT CAUSE ANALYSIS. PRODUCT CODES AND BATCH NUMBERS WERE NOT AVAILABLE; THEREFORE, A BATCH HISTORY REVIEW CANNOT BE PERFORMED AT THIS TIME TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES. FOLLOW-UP CONTACT WITH PATIENT REVEALED THE INFECTION WAS IN THE AREA OF THE INCISION SITE WHICH CULTURE INFECTION. DEPUY MITEK WILL CONTINUE TO TRACK PRODUCT COMPLAINTS OF THIS SORT. WHEN AND IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT CONTACTED THE DEPUY MITEK STATING THAT SHE HAD TWO MITEK SUPER ANCHORS IMPLANTED IN HER KNEE IN 2008 AND HAD PERSISTENT PROBLEMS WITH INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCS ANCHORS SUPER QUICK ANCHOR MBI DEPUY MITEK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1