BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR 46MM

    MDR report key: 3872093 · Received June 13, 2014

    Report

    Report Number
    3002806535-2014-00148
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    February 2, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE MEDICAL RECORDS: ADDITIONAL INFORMATION RECEIVED FROM THE LEGAL DEPARTMENT STATING THAT THE MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED DUE TO PAIN. THE SURGEON, WHO PERFORMED THE REVISION SURGERY CONCLUDED THAT THE PAIN WAS CAUSED BY ACETABULAR CUP AND/OR FEMORAL HEAD MALPOSITIONING WHICH WAS IRRITATING THE ILIOPSOAS TENDON. BLOOD METAL ION TESTS INDICATE THAT THE BLOOD LEVELS WERE NORMAL. NO METALLOSIS WAS NOTICED DURING THE REVISION SURGERY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL THE CAUSE OF THE REPORTED HIP REVISION WAS IMPLANTS MALPOSITIONING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2007. REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO ELEVATED METAL ION LEVELS AND METALLOSIS. NO FURTHER INFORMATION HAS BEEN RECEIVED.THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S NOTICE AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349012 M2A MAGNUM MODULAR HD COCR 46MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1322373

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R