BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COCRMO

    MDR report key: 1013877 · Received March 14, 2008

    Report

    Report Number
    3002806535-2008-00003
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    July 16, 2007
    Report Date
    October 23, 2007
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETROSPECTIVE REVIEW OF FILE WAS PERFORMED. DURING REVIEW, DETERMINATION WAS MADE THAT DETAILS PROVIDED MEET REPORTING REQUIREMENTS. TO ADDRESS ISSUE OF LATE SUBMISSION, A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN OPENED. THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. INITIAL INSPECTION OF COMPONENTS FOUND NO DIMENSIONAL/MANUFACTURING ERRORS THAT ACCOUNT FOR THE SEPARATION OF THE TWO COMPONENTS. FULL INVESTIGATION IS IN PROCESS BUT NOT YET COMPLETED. UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BI-POLAR ARTHROPLASTY IN 2007. SUBSEQUENTLY, REVISION PROCEDURE WAS PERFORMED TWO WEEKS LATER WHERE THE BI-POLAR AND MODULAR HEAD COMPONENTS WERE FOUND SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEAD COCRMO JDI BIOMET UK LTD. AN 0000267096

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R