BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELF CENT HIP BI-POLAR HEAD MM ID 28, MMOD 48 BRN

    MDR report key: 3672312 · Received March 11, 2014

    Report

    Report Number
    1818910-2014-14060
    Event Type
    Death
    Date Received
    March 11, 2014
    Date of Event
    November 18, 2009
    Report Date
    February 13, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWY
    PMA / PMN Number
    PK812672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    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

    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, 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
    145256 SELF CENT HIP BI-POLAR HEAD MM ID 28, MMOD 48 BRN HIP OTHER IMPLANT KWY DEPUY ORTHOPAEDICS, INC. 1818910 C39EL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death