BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6493297 · Received April 14, 2017

    Report

    Report Number
    0001825034-2017-01727
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    February 10, 2012
    Report Date
    August 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS WHICH CONFIRMED THE COMPLAINT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF PRODUCT IS BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN; HOWEVER, AN INVESTIGATION HAS BEEN INITIATED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW- UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS ¿ TAPERLOC P/N 13-103206 L/N 774840, M2A MAGNUM TAPER INSERTER P/N 139256 L/N 050100.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON OPERATIVE NOTES THAT DURING THE OPERATION, AN ABUNDANT AMOUNT OF METALLOSIS WAS PRESENT IN THE FLUID.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, ASEPTIC LYMPHOCYTE-DOMINATED VASCULITIS-ASSOCIATED LESION (ALVAL), METALLOSIS AND INFECTION. DURING THE PROCEDURE, THE FEMORAL HEAD WAS REMOVED AND REPLACED AND A DUAL MOBILITY BEARING WAS IMPLANTED. OPERATIVE REPORT NOTED THAT DURING THE OPERATION, AN ABUNDANT AMOUNT OF METALLOSIS WAS PRESENT IN THE FLUID. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT WAS REVISED APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, ASEPTIC LYMPHOCYTE-DOMINATED VASCULITIS-ASSOCIATED LESION (ALVAL) AND METALLOSIS. DURING THE PROCEDURE, THE FEMORAL HEAD WAS REMOVED AD REPLACED AND A DUAL MOBILITY BEARING WAS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275460 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 955460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R