BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2232721 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15611
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 30, 2011
    Report Date
    November 15, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS INVESTIGATION DID ADDRESS THE FEMORAL HEAD AND DID NOT IDENTIFY PRODUCT ERROR. THIS MATTER REMAINS IN LITIGATION AND FOLLOW UP ACTIVITIES ARE BEING PERFORMED BY THE DEPUY LEGAL TEAM. NO NEW INFORMATION HAS BEEN PROVIDED TO CUSTOMER QUALITY AT THIS TIME TO CHANGE INVESTIGATIVE RESULTS. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS DEVICE EVALUATION DID NOT IDENTIFY PRODUCT ERROR. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. THERE IS NO CHANGE TO THE PREVIOUS INVESTIGATIVE RESULTS. CORRECTIVE ACTION IS 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

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE THE CUP WAS LOOSE WITH ONE SCREW BROKEN. ALSO, THE LINER APPEARED TO BE MALPOSITIONED IN THE CUP. UPDATE: (B)(6) 2011 - LITIGATION PAPERS ALLEGE THE FOLLOWING: FOR THE FIRST FEW YEARS PT'S HIP IMPLANT WENT WELL. HOWEVER, IN 2010 PT BEGAN TO SUFFER SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, WEAKNESS, AND DIFFICULTY WITH EVEN SIMPLE DAILY ACTIVITIES. ADDITIONALLY, PT RISKED ELEVATED LEVELS OF COBALT AND CHROMIUM METAL IONS IN HER BLOOD STREAM. ON (B)(6) 2010, PT UNDERWENT A REVISION OF HER RIGHT HIP DUE TO LOOSENING AND PAIN. DURING THE REVISION, GROSS METALLOSIS WAS FOUND. HEAD ADDED TO COMPLAINT.

    Description of Event or Problem · 1

    UPDATE 9/18/2015- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY BY A MEDICAL PROFESSIONAL, THE REVISION OPERATIVE NOTE INDICATED METALLOSIS, METAL DEBRIS, LOOSE CUP WITH 2 LOOSE SCREWS, AND ONE SCREW THAT HAD BROKEN OFF. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. A SCREW AND THE STEM ARE BEING ADDED FOR THE ALLEGED HIGH METAL IONS. THE COMPLAINT WAS UPDATED ON: 9/18/2015.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR METALLOSIS. ADDED LAW FIRM, AGE, SURGEON AND UPDATED PRODUCT DETAILS IN IPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US NA 1082435

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention