BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 3165703 · Received June 12, 2013

    Report

    Report Number
    1818910-2013-18722
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 10, 2011
    Report Date
    May 24, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE AK8E91000. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 2132504 AND 2113786 DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. ALSO (B)(4), REVISION C, STATES THAT A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED FOR THESE PRODUCTS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. -PATIENT WAS REVISED TO ADDRESS HIP PAIN. ALL COMPONENTS WERE VERY STABLE. DOI: 2006 - DOR: (B)(6) 2011 (LEFT SIDE). **UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM DISCOMFORT, INFLAMMATION, DISLOCATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. DATE OF IMPLANT HAS BEEN PROVIDED. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. DOI: (B)(6) 2006. **UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM DISCOMFORT, INFLAMMATION, DISLOCATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. THE LINER AND HEAD ARE NOW BEING REPORTED TO ADDRESS THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265386 ARTICULEZE M HEAD 36MM +8.5 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2113786

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention