BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 1821545 · Received August 27, 2010

    Report

    Report Number
    3002806535-2010-00066
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2009. HOSPITAL REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2010, DUE TO "SQUEAKING NOISES. 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 1293448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R