BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 2844550 · Received November 26, 2012

    Report

    Report Number
    0001825034-2012-02479
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    May 24, 2010
    Report Date
    October 31, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    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. 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 2 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02478 / 02481). THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT M2A HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2010 ALLEGEDLY DUE TO ELEVATED METAL ION LEVELS, PAIN AND DIFFICULTY WALKING. A SECOND REVISION WAS ALLEGEDLY PERFORMED ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED IN THE FORM OF OPERATIVE NOTES INDICATE THAT THE REVISION ON (B)(6) 2010 WAS PERFORMED DUE TO ACETABULAR CUP LOOSENING. FURTHER INFORMATION RECEIVED IN OPERATIVE NOTES INDICATE THE REVISION PROCEDURE PERFORMED ON (B)(6) 2012 WAS DUE TO PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT M2A HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2010 ALLEGEDLY DUE TO ELEVATED METAL ION LEVELS, PAIN AND DIFFICULTY WALKING. A SECOND REVISION WAS ALLEGEDLY PERFORMED ON (B)(6) 2012 DUE TO UNKNOWN REASON. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 325120

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R