BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 45

    MDR report key: 3864654 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20618
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    September 28, 2011
    Report Date
    October 15, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    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. 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.

    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.

    Description of Event or Problem · 1

    UPDATE 27 OCT. 2015: UPDATED DOR AND ADDED EXPIRY DATES FOR PRODUCTS. UPDATED FILE HANDLER DETAILS. TAKEN FROM CLAIMSUITE UPDATE (B)(6) 2015.

    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 DUE TO TAKE PLACE (B)(6) 2011. ASR HIP RESURFACING SYSTEM (LEFT), REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: (B)(6) 2014 - ATTACHED SURGEON LETTER AND ADDED FURTHER REASON(S) FOR REVISION: AFTER REVISION THE PATIENT SUFFERED WITH PERSISTENT SCIATIC PAIN DUE TO NEUROLOGICAL IRRITATION FROM ALVAL AND RAISED ION LEVELS REMAINED HIGH POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341335 TOTAL ASR FEM IMP SIZE 45 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 1958116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention