BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36 MM +8.5

    MDR report key: 2176898 · Received July 20, 2011

    Report

    Report Number
    1818910-2011-13507
    Event Type
    Injury
    Date Received
    July 20, 2011
    Report Date
    June 20, 2011
    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
    DC, US
    Reporter Occupation
    ATTORNEY

    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

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES A65CF1000, BB3FW1000, AND 2255751. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2183702 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS 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. 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).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR RELATED ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR ALL OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT HARM AND PATIENT NAME WERE UPDATED. PPF ALSO ALLEGES INFECTION AND ELEVATED METAL IONS AFTER THE FIRST REVISION, HOWEVER, THERE IS NO INFORMATION PROVIDED IF THE USED OR IMPLANT A DEPUY PRODUCT DURING THE FIRST REVISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6), 2007, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP ON HER LEFT SIDE. ON OR ABOUT (B)(6), 2007, AFTER SUFFERING FROM DISCOMFORT IN HER LEFT HIP AND BEING DIAGNOSED WITH FASCIAL DEHISCENCE, PATIENT UNDERWENT REVISION SURGERY TO REPAIR THE FASCIAL DEFECT. IN (B)(6) 2008, PATIENT CONTINUED TO HAVE SEVERE DISCOMFORT IN HER LEFT HIP, WHICH WAS ALSO DIRECTLY CAUSING HER SIGNIFICANT PAIN IN HER KNEE. ON OR ABOUT (B)(6), 2008, PATIENT UNDERWENT HER SECOND REVISION SURGERY, TO ADDRESS THE CONTINUING SEVERE PAIN AND DISCOMFORT IN HER LEFT HIP. ON OR ABOUT (B)(6), 2008, PATIENT'S SYMPTOMS INCLUDED A GRINDING SENSATION IN THE GROIN AND PAIN IN THE GROIN, LATERAL PAIN, BURNING PAIN IN HER HIP, AND A SIGNIFICANT COXALGIC GAIT. ON OR ABOUT (B)(6), 2011, PATIENT'S BLOOD TESTS REVEALED DANGEROUSLY HIGH LEVELS OF COBALT AND CHROMIUM. PATIENT HAS BEEN ADVISED THAT SHE WILL REQUIRE IMMEDIATE REVISION SURGERY. UPON INFORMATION AND BELIEF, PATIENT IS SUFFERING LOSS OF MUSCLE MASS AND DETERIORATION OF THE SOFT TISSUE IN HER HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36 MM +8.5 TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS INC US NA 2183702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NA.