BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 50MM

    MDR report key: 2759422 · Received September 26, 2012

    Report

    Report Number
    0001825034-2012-01689
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    December 1, 2011
    Report Date
    August 28, 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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION RECEIVED IN MEDICAL RECORDS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-01687 / 01691).

    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 ONE STATES, "MATERIAL SENSITIVITY REACTIONS". NUMBER FIFTEEN STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES". THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01687 / 01691).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011, DUE TO ALLEGED ELEVATED METAL ION LEVELS AND TISSUE DESTRUCTION. THE ACETABULAR CUP, MODULAR HEAD, AND TAPER ADAPTER WERE REMOVED AND REPLACED. THE PATIENT WAS FURTHER REVISED ON (B)(6) 2012, FOR AN UNKNOWN REASON. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. 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 ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011, DUE TO ALLEGED ELEVATED METAL ION LEVELS AND TISSUE DESTRUCTION. THE ACETABULAR CUP, MODULAR HEAD, AND TAPER ADAPTER WERE REMOVED AND REPLACED. THE PATIENT WAS FURTHER REVISED ON (B)(6) 2012, FOR AN UNKNOWN REASON. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO ACETABULAR CUP LOOSENING AND METALLOSIS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO INFECTION. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. 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 MODULAR HEAD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 980760

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R