BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 2738268 · Received September 10, 2012

    Report

    Report Number
    1818910-2012-74771
    Event Type
    Death
    Date Received
    September 10, 2012
    Date of Event
    August 21, 2012
    Report Date
    November 7, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    ASR REVISION, RIGHT, ASR HIP RESURFACING, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    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 (B)(4) 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 (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.

    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 24TH OCT 2012. UPDATE- AMENDED STEM AND ADDED TAPER SLEEVE TAKEN FROM CLAIMSUITE DATED 24TH OCTOBER 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 (B)(6) EMAIL DATED 26TH SEPT 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2760707

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R