BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR 48MM

    MDR report key: 3721529 · Received April 2, 2014

    Report

    Report Number
    3002806535-2014-00102
    Event Type
    Injury
    Date Received
    April 2, 2014
    Report Date
    March 4, 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
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING REPORTED WAS FOUND IN A JOURNAL ARTICLE TITLED "FEW ADVERSE REACTIONS TO METAL ON METAL ARTICULATION IN TOTAL HIP ARTHROPLASTY IN A REVIEW STUDY ON 358 CONSECUTIVE CASES WITH 1 TO 5 YEARS FOLLOW-UP". THE OPEN ORTHOPAEDICS JOURNAL, 2012, 6, 366-370 CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS WERE NOT PROVIDED FOR THE REVISIONS MENTIONED IN THE JOURNAL ARTICLE, THEREFORE, THE FOLLOWING SECTIONS COULD NOT BE COMPLETE: DATE OF EVENT - UNKNOWN (EITHER DEC. 13, 2011 OR FEB. 8, 2012); DATE EXPLANTED - UNKNOWN (EITHER DEC. 13, 2011 OR FEB. 8, 2012). INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY JENS STÜRUP,1, LINE B. DAHL1, KARL-ERIK JENSEN2, ANNE-BIRGITTE LARSEN3 AND PETER GEBUHR.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT A BILATERAL HIP REPLACEMENT SURGERY ON MAY 4, 2009. SUBSEQUENTLY, REVISION PROCEDURES WERE PERFORMED ON DECEMBER 13, 2011 ON THE RIGHT HIP AND ON FEBRUARY 8, 2012 ON THE LEFT HIP DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199682 M2A MAGNUM MODULAR HD COCR 48MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1563687

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R