BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 54OD X 28ID

    MDR report key: 2243317 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17657
    Event Type
    Injury
    Date Received
    September 12, 2011
    Report Date
    September 10, 2011
    Manufacturer
    DEPUY IRELAND
    Product Code
    KWY
    PMA / PMN Number
    K940743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT ABLE TO CONCLUSIVELY CONFIRM THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS BY DEPUY INTERNATIONAL FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IDENTIFIED THAT IN THE ABSENCE OF COMPLAINT PRODUCTS AND PATIENT X-RAYS, INSUFFICIENT INFORMATION HAS BEEN PROVIDED TO COMPLETE A FULL INVESTIGATION.THE COMPLAINT SHALL BE CLOSED WITH AN INDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER 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

    THE PATIENT WILL BE REVISED DUE TO PSEUDOTUMOR TUMOR ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 54OD X 28ID HIP LINER KWY DEPUY IRELAND 1893517

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention