BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 4781440 · Received May 19, 2015

    Report

    Report Number
    1818910-2015-21016
    Event Type
    Death
    Date Received
    May 19, 2015
    Date of Event
    June 23, 2014
    Report Date
    May 7, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDG
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    ATTORNEY

    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. 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. (B)(4).

    Description of Event or Problem · 1

    WE HAVE BEEN INFORMED BY (B)(6) THAT THIS PATIENT IS DECEASED. THE DATE OF DEATH IS (B)(6) 2015. RIGHT XL REASON FOR REVISION: UNKNOWN PATIENT WAS REVISED ON (B)(6) 2014. THE CAUSE OF DEATH IS UNKNOWN, AND THERE HAS BEEN NO CAUSAL LINK BETWEEN THE DEATH OF THE PATIENT AND THE ASR IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324423 DEPUY ASR XL FEM IMP SIZE 46 HIP FEMORAL HEAD JDG DEPUY INTERNATIONAL LTD. 8010379 2222091

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death