BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT HV BONE CEMENT

    MDR report key: 2810115 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02291
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 6, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT REMOVAL OF NON-BIOMET PRODUCT ON (B)(6) 2012 DUE TO INFECTION. DURING THE PROCEDURE THE JOINT WAS DEBRIDED AND WASHED. A GENTMICIN LOADED BIOMET KNEE SPACER AND BIOMET COBALT HV CEMENT WAS IMPLANTED. THE PATIENT BEGAN EXPERIENCING NUMBNESS IN THE INDEXED FOOT WITHIN DAYS. WITHIN WEEKS THE PATIENT NOTED NUMBNESS IN BOTH FEET, AND WITHIN A MONTH THE PATIENT NOTED NUMBNESS IN BOTH HANDS AND FEET. THE PATIENT ALSO NOTICED WEAKNESS IN THE INDEXED LEG. IT WAS NOTED THE DOCTOR PREPARED THE TEMPORARY SPACER ADDED 4G OF TOBRAMYCIN TO THE SPACER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R