BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 4256866 · Received November 17, 2014

    Report

    Report Number
    1818910-2014-31844
    Event Type
    Death
    Date Received
    November 17, 2014
    Date of Event
    August 21, 2012
    Report Date
    November 7, 2014
    Manufacturer
    DEPUY FRANCE SAS
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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. REF. (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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION, RIGHT, ASR HIP RESURFACING, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. QUERYING LOT NUMBER FOR STEM 2771053 ON CLAIMSUITE (B)(6) 2012. UPDATE- AMENDED STEM AND ADDED TAPER SLEEVE TAKEN FROM CLAIMSUITE DATED (B)(6) 2012. LOT NUMBER PROVIDED FOR STEM IS INCORRECT. QUERYING AND WAITING FOR FURTHER INFORMATION. LOT NUMBER HAS NOW BEEN PROVIDED. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER. TAKEN FROM K(B)(6) EMAIL DATED (B)(6) 2014. UPDATE (B)(6) 2014 - NOTIFICATION RECEIVED THAT THE PATIENT IS DECEASED. NO CONFIRMATION OF DATE OF DEATH AS OF YET. ADDED PATIENT DOB AND NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741809 CORAIL2 STD SIZE 11 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 2771093

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R