BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HD COCR 42MM

    MDR report key: 3771041 · Received April 24, 2014

    Report

    Report Number
    3002806535-2014-00114
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 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
    UK
    Reporter Occupation
    PHYSICIAN

    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. EXPIRATION DATE - UNKNOWN. IMPLANT DATE - UNKNOWN.MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISON PROCEDURE WAS PERFORMED ON (B)(6), 2014 DUE TO ELEVATED METAL ION LEVELS. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250288 M2A MAGNUM MODULAR HD COCR 42MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R