BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 43

    MDR report key: 3090791 · Received May 2, 2013

    Report

    Report Number
    1818910-2013-05184
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    November 30, 2012
    Report Date
    June 18, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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

    ASR REVISION; ASR HIP RESURFACING SYSTEM - LEFT HIP; REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION. ASR HIP RESURFACING SYSTEM - LEFT. REASON(S) FOR REVISION: PAIN. KENNEDYS ID: (B)(4). ***UPDATE RECEIVED 18TH JUNE 2014. REVISION DATE AMENDED IN LINE WITH CLAIMSUITE AND SURGEON CONFIRMATION FORM. HOSPITAL NAME AMENDED.***

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192562 TOTAL ASR FEM IMP SIZE 43 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 1170392

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention