BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 2972918 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-12714
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    April 27, 2012
    Report Date
    May 21, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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

    **UPDATE: (B)(4) 2013 - LITIGATION PAPERS RECEIVED. PART AND LOT INFORMATION HAS BEEN IDENTIFIED THROUGH AN INVOICE SEARCH. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. WITH THE INFORMATION PROVIDED, THE EVIDENCE SUGGESTS THE PATIENT HAD AN ADVERSE REACTION TO METAL DEBRIS AND METALLOSIS. 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. 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

    PATIENT SEEKING LEGAL ACTION. PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES THAT THE PATIENT SUFFERS FROM NOISE, DISCOMFORT, PAIN, DIFFICULTY AMBULATING, DISLOCATION, AND ELEVATED METAL IONS. REVISION OPERATIVE NOTES INDICATED METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75748 ARTICULEZE M HEAD 36MM +5 HEAD JDI DEPUY ORTHOPAEDICS INC US 1865358

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other