BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR DIA46MM

    MDR report key: 4123020 · Received September 26, 2014

    Report

    Report Number
    3002806535-2014-00211
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS IS 2 OF 2 REPORTS BEING SUBMITTED FOR THE SAME EVENT. ALSO SEE: 3002806535-2014-00210.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO ARMD AND MECHANICAL COMPLICATION OF THE INTERNAL JOINT PROSTHESIS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601093 M2A MAGNUM MODULAR HD COCR DIA46MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1747895

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R