BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 3943257 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23703
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    DEPUY INTL., LTD.8010379
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CONTACTED JNJ, AS PER CUSTOMER: I HAVE BEEN REQUESTED TO BE A REPRESENTATIVE PLAINTIFF IN A CLASS ACTION LAW SUIT AGAINST JOHNSON AND JOHNSON. ON (B)(6) 2009 I HAD- A HIP IMPLANT - A DEPUY PINNACLE ULTAMET. CONTINUED PAIN RESULTED IN BLOOD METAL TESTING BEING DONE IN (B)(6) 2012 SHOWING CHROMIUM PLASMA COUNT OF 241.34 AND COBALT, PLASMA COUNT OF 219.59. AN IMAGING REPORT SHOWS "DEBRIS-FILLED MASS." A FURTHER FULL BLOOD COUNT DONE ON (B)(6) 2012 INDICATED LEVELS OF CHROMIUM AT 90.6 AND COBALT AT 9.62 A SURGERY WAS DONE ON (B)(6) 2012 TO REMOVE THE IMPLANT AND REPLACE IT WITH A CERAMIC JOINT. BECAUSE OF CONTINUED PAIN AND DISCOMFORT, I UNDERTOOK AN MRI IN (B)(6) 2014 WHICH INDICATES A MODERATE SIZED JOINT EFFUSION AD EXTRACAPSULAR EXTENSION OF FLUID. THIS IS INDICATIVE OF INFLAMMATION AS A RESULT OF METALLOSIS. DOI: (B)(6) 2009 DOR: (B)(6) 2012. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED JNJ, AS PER CUSTOMER: I HAVE BEEN REQUESTED TO BE A REPRESENTATIVE PLAINTIFF IN A CLASS ACTION LAW SUIT AGAINST JOHNSON AND JOHNSON. ON (B)(6) 2009, I HAD- A HIP IMPLANT - A DEPUY PINNACLE ULTAMET. CONTINUED PAIN RESULTED IN BLOOD METAL TESTING BEING DONE IN (B)(6) 2012 SHOWING CHROMIUM PLASMA COUNT OF 241.34 AND COBALT, PLASMA COUNT OF 219.59. AN IMAGING REPORT SHOWS " DEBRIS-FILLED MASS" A FURTHER FULL BLOOD COUNT DONE ON (B)(6) 2012, INDICATED LEVELS OF CHROMIUM AT 90.6 AND COBALT AT 9.62 A SURGERY WAS DONE ON (B)(6) 2012 TO REMOVE THE IMPLANT AND REPLACE IT WITH A CERAMIC JOINT. BECAUSE OF CONTINUED PAIN AND DISCOMFORT, I UNDERTOOK AN MRI IN (B)(6) 2014 WHICH INDICATES A MODERATE SIZED JOINT EFFUSION AD EXTRACAPSULAR EXTENSION OF FLUID. THIS IS INDICATIVE OF INFLAMMATION AS A RESULT OF METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421463 UNKNOWN DEPUY FEMORAL HEAD HIP FEMORAL HEAD KWA DEPUY INTL., LTD.8010379 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other