BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 2033442 · Received March 24, 2011

    Report

    Report Number
    3002806535-2011-00038
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS REC'D. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT WAS FILED ON (B)(6) 2011.

    Description of Event or Problem · 1

    PT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6) 2008. REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 DUE TO PAIN AND CLUNKING WHEN WEIGHT BEARING. IT WAS REPORTED THERE WERE NO SIGNS OF METAL DEBRIS WITH NORMAL, HEALTHY TISSUE FOUND. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD KWA BIOMET UK LTD. NA 1478397

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R