BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE M 36MM +1.5

    MDR report key: 3021457 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-14475
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    April 24, 2012
    Report Date
    March 20, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: A REVIEW OF THE MANUFACTURING RECORDS AND THE COMPLAINTS DATABASE DID NOT HIGHLIGHT ANY ANOMALIES OR ANY PREVIOUS TRENDS FOR THIS ISSUE. NO PRODUCT OR FURTHER INFORMATION WAS RECEIVED AND SO NO FURTHER INVESTIGATION COULD BE CARRIED OUT. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123338 ARTICUL/EZE M 36MM +1.5 HEAD BALL JDI 8010379 DEPUY INTL., LTD. 3106490

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention