BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 3464685 · Received November 12, 2013

    Report

    Report Number
    0001825034-2013-05231
    Event Type
    Injury
    Date Received
    November 12, 2013
    Date of Event
    July 4, 2008
    Report Date
    October 14, 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 6 OF 8 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-02303-1/02304-1 AND 05228/05233).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA FROM DR (B)(6) REGARDING PATIENTS ENROLLED IN A MOM CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. DURING POST OPERATIVE MONITORING AND TESTING, A CYSTIC MASS WAS NOTED IN THE LEFT HIP AND SOLID MASSES WERE NOTED IN THE RIGHT HIP. THE CYSTIC MASS ON THE LATERAL AREA OF THE LEFT HIP MEASURED 4.3 X 3.5 X 2.6CM. THE SOLID MASS ON THE ANTERIOR AREA OF THE RIGHT HIP MEASURED 4.3 X 4.2 X 1.7CM. THE SOLID MASS ON THE POSTERIOR AREA OF THE RIGHT HIP MEASURED 4.4 X 2.5 X 2.6CM. 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
    581212 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 169510

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R