BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORAIL2 STD SIZE 10

    MDR report key: 3672280 · Received March 11, 2014

    Report

    Report Number
    1818910-2014-14057
    Event Type
    Death
    Date Received
    March 11, 2014
    Date of Event
    November 18, 2009
    Report Date
    February 13, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    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. 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

    CONCLUSION AND JUSTIFICATION STATUS: THE RECEIVED MEDICAL RECORDS WERE TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED CONCLUDING THAT THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF MANUFACTURING RECORDS AND COMPLAINTS DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. 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

    PATIENT DEATH IN 2011. EXACT DATE HAS NOT BEEN PROVIDED AT THIS TIME. THIS COMPLAINT IS STILL UNDER INVESTIGATION. 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 CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE 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.

    Additional Manufacturer Narrative · 1

    THIS IS A NEW CLAIM CONCERNING A HIP PROSTHESIS COMPOSED OF AN ARTICULEZE FEMORAL HEAD, A CORAIL FEMORAL STEM AND A BIPOLAR HEAD. ON (B)(6) 2009, THE PATIENT UNDERWENT A LEFT HIP SURGERY(ARTHROPROSTHESIS IMPLANT SURGERY) AT THE HOSPITAL (B)(6) WHERE HE RECEIVED A DEPUY ARTICULEZE PROSTHESIS. THE DIAGNOSIS AT ENTRANCE WAS 'LEFT COXALGY DUE TO SUSPECT NEOPLASTIC LESION '; THE DIAGNOSIS AT DISCHARGE WAS 'PATHOLOGICAL FRACTURE OF THE LEFT FEMOR'S NECK'. ACCORDING TO THE LAWYER'S LETTER , SHORTLY AFTER THE IMPLANT, THE PATIENT STARTED TO SUFFER OF AN INFLAMMATORY PROCESS AT THE LEFT HIP, ALLEGEDLY DUE TO THE METAL IONS RELEASED BY THE PROSTHESIS. FROM (B)(6) 2009 THE PATIENT WAS HOSPITALIZED AGAIN IN THE ONCOLOGIC WARD OF THE SAME HOSPITAL TO UNDERGO TO SEVERAL EXAMS, THE DIAGNOSIS AT ENTRANCE WAS 'PULMONARY K'. FROM (B)(6) 2010 THE PATIENT WAS TREATED WITH TARCEVA, A DRUG USED FOR NON SMALL CELL LONG CANCER. BETWEEN (B)(6) 2010 THE PATIENT WAS HOSPITALIZED AGAIN DUE TO THE SEVERE PAIN CONCERNING THE IMPLANTED HIP, STARTED MONTHS BEFORE. THE DIAGNOSIS AT ENTRANCE WAS 'LEFT HIP PROSTHESIS INFLAMMATION'; THE DIAGNOSIS AT DISCHARGE WAS 'LUNG OF BRONCHUS MALIGNANT TUMOR. THE PATIENT WAS TRANSFERRED TO THE MEDICINE WARD AS THE ORTHOPAEDIC DOCTORS EXCLUDED THE OCCURRENCE OF FRACTURES AND/OR INFLAMMATORY PROCESSES TO THE LEFT IMPLANT. THE DIAGNOSIS AT DISCHARGE WAS 'LUNGS' NEOPLASIA WITH BONE METASTASES''. ACCORDING TO THE COUNTERPARTS' LAWYER , THE PATIENT CONTRACTED THE CARCINOMA AS A CONSEQUENCE OF DEPUY PROSTHETIC IMPLANT. THE PATIENT DIED IN 2011. COMPLAINT DESCRIPTION: UPDATE (B)(6) 2017: ADDITIONAL INFORMATION RECEIVED. UPDATED LEFT SIDE, PRODUCT DESCRIPTION SELF CENT HIP BI-POLAR HEAD MM ID 28, MMOD 48, ARTICUL/EZE BALL 28 +8.5 BL 12/14 CONE, LOT NUMBER 1871546, DATE OF IMPLANT, SYMPTOMS FOR REVISION LEFT COXALGICA DUE TO SUSPECTED NEOPLASTIC LESION, PATHOLOGICAL FRACTURE OF THE LEFT FEMORAL NECK. THIS COMPLAINT WAS UPDATE ON (B)(6) 2017. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, 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.

    Description of Event or Problem · 1

    THIS IS A NEW CLAIM CONCERNING A HIP PROSTHESIS COMPOSED OF AN ARTICULEZE FEMORAL HEAD, A CORAIL FEMORAL STEM AND A BIPOLAR HEAD. ON (B)(6) 2009, UNDERWENT A LEFT HIP SURGERY(ARTHROPROSTHESIS IMPLANT SURGERY) WHERE HE RECEIVED A DEPUY ARTICULEZE PROSTHESIS. THE DIAGNOSIS AT ENTRANCE WAS 'LEFT COXALGY DUE TO SUSPECT NEOPLASTIC LESION '; THE DIAGNOSIS AT DISCHARGE WAS 'PATHOLOGICAL FRACTURE OF THE LEFT FEMOR'S NECK'. ACCORDING TO THE LAWYER'S LETTER , SHORTLY AFTER THE IMPLANT, THE PATIENT STARTED TO SUFFER OF AN INFLAMMATORY PROCESS AT THE LEFT HIP, ALLEGEDLY DUE TO THE METAL IONS RELEASED BY THE PROSTHESIS. FROM (B)(6) 2009 THE PATIENT WAS HOSPITALIZED AGAIN IN THE ONCOLOGIC WARD OF THE SAME HOSPITAL TO UNDERGO TO SEVERAL EXAMS, THE DIAGNOSIS AT ENTRANCE WAS 'PULMONARY K'. FROM (B)(6) 2010 THE PATIENT WAS TREATED WITH TARCEVA, A DRUG USED FOR NON SMALL CELL LONG CANCER. BETWEEN (B)(6) 2010 AND (B)(6) 2010, THE PATIENT WAS HOSPITALIZED AGAIN DUE TO THE SEVERE PAIN CONCERNING THE IMPLANTED HIP, STARTED MONTHS BEFORE. THE DIAGNOSIS AT ENTRANCE WAS 'LEFT HIP PROSTHESIS INFLAMMATION'; THE DIAGNOSIS AT DISCHARGE WAS 'LUNG OF BRONCHUS MALIGNANT TUMOR. THE PATIENT WAS TRANSFERRED TO THE MEDICINE WARD AS THE ORTHOPAEDIC DOCTORS EXCLUDED THE OCCURRENCE OF FRACTURES AND/OR INFLAMMATORY PROCESSES TO THE LEFT IMPLANT. THE DIAGNOSIS AT DISCHARGE WAS 'LUNGS' NEOPLASIA WITH BONE METASTASES''. ACCORDING TO THE COUNTERPARTS' LAWYER , CONTRACTED THE CARCINOMA AS A CONSEQUENCE OF DEPUY PROSTHETIC IMPLANT. THE PATIENT DIED IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145205 CORAIL2 STD SIZE 10 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 2715841

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death