BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY STEM

    MDR report key: 2970650 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-02255
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    June 4, 2012
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS AND X-RAYS WERE PROVIDED AND REVIEWED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE NEWLY ADDED PRODUCT AS THE REQUIRED PRODUCT AND LOT CODE 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 AT THIS TIME. 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 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

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, WHICH WAS CAUSING PAIN. CLINICAL REPORT FOR THE SAME REVISION DATE INDICATES THE REASON FOR THE PATIENTS REVISION WAS ADVERSE TISSUE REACTION TO MOM. 1/29/2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION CORROSION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74726 UNKNOWN DEPUY STEM STEM KWA DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR