BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED DEPUY STEM

    MDR report key: 2970598 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-12639
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    November 20, 2012
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED FOR METAL ON METAL DEBRIS IN THEIR HIP. UPON REVISION CORROSIVE MATERIAL WAS FOUND. DOI: (B)(6) 2006 DOR: (B)(6) 2012 (LEFT HIP). THE MANUFACTURER OF THE PRODUCTS IS UNKNOWN BUT IT IS REASONABLE TO ASSUME SINCE THE PATIENT WAS IMPLANTED ON THE SAME DATE AS THEIR RIGHT HIP, WHICH HAD DEPUY, THAT THEIR LEFT HIP HAD DEPUY AS WELL. WE WILL UPDATE ACCORDINGLY AS INFORMATION IS RECEIVED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE REPORT HAS BEEN CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. AFTER REVIEW THE INVESTIGATION WAS NOT HOWEVER ABLE TO CONCLUSIVELY DETERMINE A ROOT CAUSE OR IDENTIFY PRODUCT ERROR. 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 THE PRODUCT OR 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

    THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED FOR METAL ON METAL DEBRIS IN THEIR HIP. UPON REVISION CORROSIVE MATERIAL WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74733 UNIDENTIFIED DEPUY STEM STEM KWA DEPUY ORTHOPAEDICS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR