BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR DIA 54MM

    MDR report key: 3950014 · Received July 22, 2014

    Report

    Report Number
    3002806535-2014-00174
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    November 7, 2013
    Report Date
    June 26, 2014
    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
    FI
    Reporter Occupation
    PATIENT

    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. THIS IS 2 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. ALSO SEE: 3002806535-2014-00173.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY LEFT HIP SURGERY ON (B)(6) 2010. PATIENT STATES THAT IMPLANTS MADE A SQUEAKING NOISE IMMEDIATELY AFTER SURGERY. REVISION SURGERIES WERE PERFORMED ON (B)(6) 2011 AND (B)(6) 2013, DUE TO PATIENT COMPLAINTS OF ELEVATED METAL ION LEVELS AND SOFT TISSUE DESTRUCTION. 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
    428825 M2A MAGNUM MODULAR HD COCR DIA 54MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1760151

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R