BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TAPER ADAPTER 42-50MM MINUS 6MM

    MDR report key: 2183302 · Received July 28, 2011

    Report

    Report Number
    1825034-2011-00589
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 10, 2010
    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." THIS REPORT FILED (B)(4), 2011. (B)(4)

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2005 AND PER THE PATIENT'S REPORT, A REVISION PROCEDURE OCCURRED ON (B)(6), 2010 DUE TO ELEVATED METAL IONS AND PSEUDOTUMOR. REVIEW OF INVOICE HISTORY CONFIRMED THAT THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. FURTHER INFORMATION PROVIDED INDICATES THAT THE ACETABULAR CUP WAS NOTED BY THE SURGEON TO BE MALPOSITIONED AND WAS ALSO REMOVED AND REPLACED WITH A COMPETITOR'S ACETABULAR CUP. PATIENT ALLEGES THAT A SECOND REVISION SURGERY HAS TAKEN PLACE DUE TO LACK OF BONE INGROWTH INTO THE COMPETITOR'S CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM TAPER ADAPTER 42-50MM MINUS 6MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 555610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R