BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM MODULAR HEAD

    MDR report key: 1021613 · Received March 14, 2008

    Report

    Report Number
    1825034-2008-00081
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K032396
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A MANDATORY MEDWATCH REPORT WAS RECEIVED ON 2/19/08 FROM THE USER FACILITY. THIS REPORT FILED ON MARCH 14, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY IN 2007. SUBSEQUENTLY, PT WAS REVISED IN 2008 SECONDARY TO PAIN AND INSTABILITY, AND REPEATED DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36MM MODULAR HEAD JDI JDI BIOMET, INC. NA 765090

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R