BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMA STD OFFSET L SZ 3

    MDR report key: 3823927 · Received May 21, 2014

    Report

    Report Number
    1818910-2014-19141
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    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. 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. 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

    DECEASED PATIENT - (INFO THAT WE HAVE AT THIS TIME IS BELOW). H) WHEN WERE THEY FIRST OPERATED ? RESPONSE: (B)(6) HOSPITAL. I) DID THEY UNDERGO REVISION SURGERY? RESPONSE: NO. J) WHAT IS THERE MEDIAL HISTORY, AGE PERSONAL PROFILE ETC? RESPONSE : AGE IS (B)(6), MEDICAL HISTORY; PAIN WHILE WALKING. K) WHAT WAS THE CAUSE OF DEATH? RESPONSE : NOT KNOW. L) HOW AND WHEN DID WE GET TO KNOW ABOUT THEIR DEATH? RESPONSE: RELATIVE(BROTHER) ON (B)(6) 2013. M) WHAT IS THE MEDICAL REASON RECORDED FOR THEIR DEATH? RESPONSE: NOT KNOW. N) ANY OTHER RELEVANT DETAILS / FACTS. RESPONSE: NOT KNOW. UPDATE - ADDED HIP SIDE, ADDED PRODUCTS X 4, SURGEON AND SURGERY DATE. TAKEN FROM FURTHER INFO EMAIL WITH THE ALERT DATE OF (B)(6) 2014. RIGHT HIP. UPDATE - AMENDED SURGERY DATE, TAKEN FROM EMAIL DATED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303211 PROXIMA STD OFFSET L SZ 3 HIP FEMORAL STEM/SLEEVE JDI DEPUY INTERNATIONAL LTD. 8010379 2084182

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death