BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A MAGNUM HIP

    MDR report key: 3191817 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02271
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 14, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS LIMITED INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR (B)(6) REGARDING PATIENTS ENROLLED IN A (B)(6) STUDY. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02271 / 02272).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR. PAUL GROSSO REGARDING PATIENTS ENROLLED IN A (B)(6) STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2008 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. DURING POST OPERATIVE MONITORING AND TESTING CYSTS WERE NOTED. THE CYST ON THE LATERAL AREA OF THE RIGHT HIP MEASURED 4.3 X 3.4 X 2.6CM AND THE CYST ON THE LATERAL AREA OF THE LEFT HIP MEASURED 3.5 X 4.5 X 2.2CM. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290495 UNKNOWN M2A MAGNUM HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R