BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 44MM

    MDR report key: 2945898 · Received February 6, 2013

    Report

    Report Number
    0001825034-2013-00238
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    September 17, 2012
    Report Date
    January 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 6 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00233 / 00239). 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 PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT A RIGHT HIP REVISION OCCURRED ON (B)(6) 2011 AND A LEFT HIP REVISION OCCURRED ON (B)(6) 2012 ALLEGEDLY DUE TO PAIN, CLUNKING SENSATION, TISSUE/BONE DAMAGE, DYSFUNCTION, LOSS OF RANGE OF MOTION AND ELEVATED COCR METAL ION LEVELS. A REVIEW OF INVOICE HISTORY CONFIRMED ALL SURGERY DATES AND INDICATES THAT THE HEAD AND ADAPTER WERE REMOVED DURING THE RIGHT HIP REVISION AND THAT THE HEAD, ADAPTER AND CUP WERE REMOVED DURING THE LEFT REVISION. 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
    51059 M2A-MAGNUM MODULAR HEAD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 717860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R