BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SUMMIT STEM

    MDR report key: 2970076 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-03973
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    February 6, 2013
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    REVISION SURGERY OPERATIVE NOTES WERE PROVIDED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REPORT STATES PATIENT WAS REVISED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73005 UNKNOWN DEPUY SUMMIT STEM HIP STEM JDI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention