BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 4133785 · Received October 1, 2014

    Report

    Report Number
    1818910-2014-29233
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    January 28, 2013
    Report Date
    November 3, 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
    IT
    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

    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. WWCAPA (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

    ASR REVISION, ASR XL, REASON FOR REVISION: UNKNOWN. PLEASE NOTE THAT THIS PATIENT IS DECEASED. DATE OF DEATH IS (B)(6) 2014. UPDATE: (B)(6) 2014 - CORRECTED PATIENTS NAME TO (B)(6) ATTACHED NEW ALERT. UPDATE: (B)(6) 2014 - ADDED EXPIRY DATES TO THE CUP AND HEAD AND MANUFACTURING DATE, EXPIRY DATE AND LOT NUMBERS TO THE STEM AND THE SLEEVE. LOT NUMBER FOR THE STEM IS INCORRECT (2327936) HOWEVER, LOT NUMBER 2327926 MATCHES SO HAVE USED THAT.

    Description of Event or Problem · 1

    ASR REVISION: ASR XL. REASON FOR REVISION: UNKNOWN. PLEASE NOTE THAT THIS PATIENT IS DECEASED. DATE OF DEATH IS (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611152 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 2183159

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R