BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 2893216 · Received January 2, 2013

    Report

    Report Number
    1818910-2013-10058
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 5, 2012
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 181910-2012-83186. THIS REPORT, 1818910-2013-10058, WILL BE REJECTED. 181910-2012-83186 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. PATIENT ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757 UNKNOWN DEPUY FEMORAL HEAD FEMORAL HEAD KXA DEPUY INTL., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention