BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+12

    MDR report key: 4202665 · Received October 27, 2014

    Report

    Report Number
    1818910-2014-30704
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 7, 2014
    Report Date
    March 19, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. 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 AT THIS TIME.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

    PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN. LAB RESULTS FROM (B)(6) 2012, (B)(6) 2013, AND (B)(6) 2014 INDICATED THE METAL ION LEVELS WERE BELOW 7PPB. THERE WAS NO MENTION OF METALLOSIS OR PSEUDOTUMORS. PART/LOT IS BEING UPDATED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, ELEVATED LEVELS OF COBALT AND CHROMIUM, AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. IT WAS NOTED DURING THE REVISION SURGERY THAT THERE WAS METALLOSIS AND A PSEUDOTUMOR.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED RINGING IN EARS, B12 AND IRON DEFICIENCY, CARDIOMYOPATHY, IRREGULAR HEARTBEAT, PERIPHERAL NEUROPATHY, TINGLING, NUMBNESS, BURNING, MDS SYDROME, ANXIETY, MASS IN LOWER RIGHT QUADRANT, PATIENT FATIGUED IN AFTERNOON AND GROIN PAIN. MEDICAL RECORDS AND REVISION SURGICAL REPORT NOTED POPPING AND CLICKING OCCASIONALLY, PSEUDOTUMOR AND SIGNIFICANT FIBROSIS. CT SCAN REPORTED SUSPICIOUS LESIONS IN SOFT TISSUES ABOUT THE PELVIS PARTICULARLY THE MUSCLES WITH THE MOST SIGNIFICANT IN THE ILIOPSOAS REGION. THE LAB RESULTS WITHIN THE MEDICAL RECORDS REPORTED THE METAL IONS WERE LESS THAN 7 PARTS PER BILLION. NO PARTICLES OR DEBRIS WERE REPORTED AND NO METALLOSIS REPORTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684860 12/14 ARTICUL 40MM M SPEC+12 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2718786

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention