BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT HV BONE CEMENT 40G

    MDR report key: 2831644 · Received November 14, 2012

    Report

    Report Number
    0001825034-2012-02403
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    December 21, 2011
    Report Date
    October 16, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    PK051496
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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: ADVERSE EVENTS IT STATES, THE MOST FREQUENT ADVERSE EVENTS ARE: AND LISTS, "LOOSENING OR DISPLACEMENT OF THE PROSTHESIS." 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

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT HV BONE CEMENT 40G BONE CEMENT LOD BIOMET ORTHOPEDICS N/A 322130

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R