BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ASR HIP

    MDR report key: 3010206 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-14025
    Event Type
    Death
    Date Received
    March 19, 2013
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: AS THERE WERE NO PRODUCTS RETURNED AND NO LOT NUMBERS RECEIVED, NO INVESTIGATION COULD TAKE PLACE AND A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE.SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> REVISION OF THE DEVICE HAS BEEN REPORTED AND THERE WAS NO ALLEGATION THAT THE DEVICE WAS A CONTRIBUTOR TO THIS EVENT. NO EXPLANTED DEVICES HAVE BEEN RECEIVED IN RESPECT OF THIS PATIENT FOR ANALYSIS. IF FURTHER INFORMATION IS RECEIVED INDICATING THAT THE DEVICE WAS A CONTRIBUTOR OR THERE IS AN ALLEGED DEFICIENCY OF THE DEVICE THEN THIS EVENT WILL BE RE-OPENED FOR EVALUATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    WE RECEIVE THIS REPORT FROM OUR LEGAL DEPT. THE PATIENT WAS IMPLANTED WITH AN UNKNOWN MODEL OF PROXIMA DEVICE ON (B)(4) 2007. THE PATIENT WAS TOLD THAT HE HAD TO BE REVISED BECAUSE (LITERALLY) THE DEVICES IMPLANTED WERE TOXIC. ALSO, IN THE REPORT THE LAWYER REPORTED THAT LIKEWISE ASR CASE, THE CR-CO RESULTED IN THE PATIENT BLOOD AS PER BLOOD TEST PERFORMED ON (B)(4) 2012. ON (B)(4) 2014, (B)(4) HAVE CONFIRMED THE PRODUCT IS AN ASR PRODUCT.

    Description of Event or Problem · 1

    THE PATIENT WAS TOLD THAT HE HAD TO BE REVISED THE CR-CO RESULTED IN THE PATIENT BLOOD

    Description of Event or Problem · 1

    CLAIM LETTER ALLEGES PATIENT IS A DECEASED FROM PANCREATIC NEOPLASM. ON (B)(6)2017 HE WAS DIAGNOSED TO HAVE A PANCREATIC TUMOR. (B)(6)2017 DIAGNOSED METASTASIS STAGE IV PANCREATIC NEOPLASM; ASCITES AND SEVERE PYORIC OBSTRUCTION. IT ALSO ALLEGE THAT TUMOR WAS LINK TO PROLONGED EXPOSURE TO ELEVATED METAL IONS FROM IMPLANTATION OF THE PROXIMA PROSTHETIC HIP.PRIOR TO HIS DEATH ALLEGES ELEVATED METAL IONS THEN DEVELOPED PANCREATIC NEOPLASM. THERE WERE SYSTEMIC EFFECT FROM METAL PRODUCTS THAT CAUSE ORGAN TOXICITY, CARCINOGENSIS AND TERATOGENESIS, DEPOSIT OF METAL PARTICLES IN THE NS, ORGAN AND BLOOD CIRCULATION AND ACCUMULATION OF METAL IONS WITH KIDNEY FAILURE. DUE TO TOXICITY CAUSED BY THE RELEASE OF METAL PARTICLES PATIENT DEVELOPED NEOPLASM. THE CLIENTS HEIRS ARE DEMANDING FULL COMPENSATION FOR THE DAMAGES SUFFERED FROM THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114676 UNKNOWN ASR HIP HIP OTHER IMPLANT JDI DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R