BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MOM PROSTHESIS

    MDR report key: 3233698 · Received July 18, 2013

    Report

    Report Number
    3002806535-2013-00134
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    December 11, 2012
    Report Date
    June 21, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2006. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 DUE TO PSEUDOTUMOR. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334957 BIOMET MOM PROSTHESIS PROTHESIS, HIP KWA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R