BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 52MM O.D. X 46MM I.D.

    MDR report key: 2172019 · Received July 22, 2011

    Report

    Report Number
    1825034-2011-00590
    Event Type
    Injury
    Date Received
    July 22, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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: "MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS." "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." DATE OF EVENT - NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE RIGHT TOTAL HIP ARTHROPLASTY AND THAT PER THE PATIENT'S REPORT, REVISION SURGERY IS NECESSARY DUE TO ELEVATED METAL IONS AND PSEUDOTUMOR. REVIEW OF INVOICE HISTORY REVEALED THAT A TOTAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2005. THERE HAS BEEN NO REPORT OF A REVISION PROCEDURE AND NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP 52MM O.D. X 46MM I.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 648550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R