BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM +3

    MDR report key: 2760372 · Received September 26, 2012

    Report

    Report Number
    0001825034-2012-01666
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    July 25, 2012
    Report Date
    August 27, 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
    CA, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-01666 / 01667).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 AND THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE ALLEGEDLY DUE TO PAIN, ELEVATED METAL IONS, INFLAMMATION AND LACK OF MOBILITY. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATE AND THAT A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012 TO REPLACE THE MODULAR HEAD AND TAPER ADAPTER. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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 SELEX/MAGNUM MODULAR HEAD 40MM +3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 556720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R