BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3943601 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23751
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 22, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    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

    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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, SWELLING, BURSITIS, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, METAL TOXICITY, EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT, NERVE DAMAGE, BONE EROSION, PSEUDOTUMORS, NEED FOR ADDITIONAL SURGERY TO REPAIR, REMOVE AND/OR REPLACE THE HIP.

    Description of Event or Problem · 1

    UPDATE MAY 30, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES TISSUE DAMAGE DUE TO METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, EXAMINATION NOTES STATED THAT PATIENT HAD SOME DISCOMFORT, SORENESS AFTER WORKING OUT, RIGHT LEG RESTLESS SYNDROME WITH PAIN, STIFFNESS AND MYOCLONIC JERKS. REVISION NOTES REPORTED A BULBOUS SYNOVIUM THAT WAS GREEN-BLACK AND MILKY. THERE WAS ALSO A SYNOVIAL CYST NOTED. THERE WERE NO FRETTING OR CORROSION OF THE FEMORAL COMPONENT. LABORATORY RESULTS FOR METAL IONS WERE ABOVE 7PPB. STEM HAS BEEN ADDED. PRODUCT CODES AND LOT NUMBERS WERE PROVIDED. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON JUN 7, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422352 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1818910 2772251

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other