BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SELEX/MAGNUM MOD HD 40MM

    MDR report key: 3181712 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02126
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 23, 2011
    Report Date
    May 28, 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
    VA, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - S031140, LOT NUMBER - 410890, EXPIRATION DATE - JAN 31, 2015, MANUFACTURE DATE ¿ JAN 14, 2005. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - S331140, LOT NUMBER - 225960, EXPIRATION DATE - MAR 31, 2017, MANUFACTURE DATE ¿ MAR 5, 2007. THE PREVIOUS REVISION PROCEDURE ON NOVEMBER 9, 2009 WAS REPORTED ON MEDWATCH NUMBERS 1825034-2012-00946-1/00949-1).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(4) 2009, DUE TO PAIN, OSTEOLYSIS, AND SQUEAKING FROM HIP. OPERATIVE REPORTS FROM REVISION SURGERY NOTE PRESENCE OF METAL DEBRIS AND GRAY SOFT TISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT WAS REVISED ON (B)(6) 2011, DUE TO UNKNOWN REASONS. THE BIOMET HEAD WAS 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
    283224 UNKNOWN SELEX/MAGNUM MOD HD 40MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R