BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 4200637 · Received October 24, 2014

    Report

    Report Number
    1818910-2014-30647
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    February 22, 2011
    Report Date
    October 9, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDG
    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. (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 ¿ RECOMMENDED ASR REVISION - LEFT HIP. UPDATE FROM (B)(4) SPREADSHEET DATED (B)(6) 2011- ADDED REVISION DATE, SURGEON, HOSPITAL AND PRODUCT. THIS PATIENT IS BI-LATERAL. PLEASE SEE (B)(4) FOR LEFT HIP REVISION. UPDATE - QUERYING IMPLANT DATE AS IT IS BEFORE MANUFACTURING DATES. ADDED TYPE OF REPLACEMENT, REVISION DATE, REASON FOR REVISION, ADDED PRODUCTS X 3 AND CORRECTED BI-LATERAL COMMENT. TAKEN FROM CLAIMSUITE DATED 9TH OCTOBER 2014. REASON(S) FOR REVISION: PAIN, XL. THIS PATIENT IS BI-LATERAL. PLEASE SEE (B)(4) FOR RIGHT HIP REVISION. UPDATE - ADDED CORRECT IMPLANT DATE - SEE EMAIL DATED 17TH OCTOBER 2014. UPDATE - QUERYING REASON FOR REVISION WHICH COMP BECAME LOOSE - COMPONENT LOOSENING PREVIOUSLY MISSED. 23RD OCT 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678561 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD JDG DEPUY INTERNATIONAL LTD. 8010379 2445352

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention