BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INSRT-6

    MDR report key: 2807738 · Received October 29, 2012

    Report

    Report Number
    0001825034-2012-02172
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    August 25, 2009
    Report Date
    October 1, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 10 OF 16 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02075 / 02077, 02172 / 02174, 02075-1 / 02077-1, 02172-1 / 02174-1 AND 02236 / 02239).

    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. EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 4 OF 6 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2012-02075 / 02077 & 02172 / 02174).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS A LEFT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2009 AND A RIGHT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010. FURTHER REVIEW OF MEDICAL RECORDS AND INVOICES REVEALED THAT A TWO STAGE LEFT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2009 TO REMOVE COMPONENTS AND IMPLANT SPACERS DUE TO INFECTION; WITH REIMPLANTATION OF TOTAL HIP OCCURRING ON (B)(6) 2009. REVIEW OF LABORATORY TEST RESULTS PROVIDED INDICATE ELEVATED METAL ION LEVELS. 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 TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS A LEFT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2009 AND A RIGHT HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010. FURTHER REVIEW OF MEDICAL RECORDS AND INVOICES REVEALED THAT A TWO STAGE LEFT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2009 TO REMOVE COMPONENTS AND IMPLANT SPACERS DUE TO INFECTION; WITH REIMPLANTATION OF TOTAL HIP OCCURRING ON (B)(6) 2009. 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 52-60MM TPR INSRT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 541630

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R