BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK ACL IMPLANTS

    MDR report key: 4733570 · Received April 28, 2015

    Report

    Report Number
    1221934-2015-00725
    Event Type
    Injury
    Date Received
    April 28, 2015
    Report Date
    March 31, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK MEDICAL SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAINS RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE FOLLOWING ISSUE WAS DISCOVERED VIA A PUBLISHED COHORT STUDY BY THE MITEK SAFETY OFFICER 3 YEARS AFTER HAVING ACL RECONSTRUCTION BETWEEN 2007-2008 USING MITEK MILAGRO ANCHORS. AUTHOR: CHARLES L. COX, MD, MPH, KURT P. SPINDLER, MD, JAMES P. LEONARD, MD, BRENT J. MORRIS, MD, WARREN R. DUNN, MD, MPH, AND EMILY K. REINKE, PHD REFERENCE: THE JOURNAL OF BONE & JOINT SURGERY D JBJ S. ORG. DO NEWER GENERATION BIOABSORBALE SCREWS BECOME INCORPORATED INTO BONE AFTER ACL RECONSTRUCTION? INVESTIGATION PERFORMED AT (B)(6). CYST FOUND UPON RADIOLOGICAL INVESTIGATION BY RESEARCHING DOCTOR. CYST TREATMENT NOT PRESENTED IN PAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279525 MITEK ACL IMPLANTS ACL IMPLANTS HWC DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other