BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2903854 · Received January 9, 2013

    Report

    Report Number
    1818910-2013-00148
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 23, 2012
    Report Date
    April 24, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    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

    CORRECTED/UPDATED DATA: (DATE OF REPORT); (EVENT DESCRIPTION); (IMPLANT DATE); (DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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. (B)(4).

    Description of Event or Problem · 1

    ASR REVISION; ASR XL SYSTEM - LEFT HIP; REASON FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL 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. LEFT HIP. ASR XL SYSTEM. REASON FOR REVISION UNKNOWN. (B)(4). UPDATE- ADDED REASON FOR REVISION, UPDATED ORIGINAL SURGERY DATE TAKEN FROM CLAIMSUITE DATED 22ND JAN 2013. REASON(S) FOR REVISION: PAIN AND ALVAL / SOFT TISSUE REACTION. UPDATE: ADDED FURTHER REVISION REASON AND PRODUCT. RECEIVED: FEBRUARY 22ND 2013. 24 APRIL 2015 - UPDATE - RCVD AMENDED IMPLANT DATE - CONF THAT PROVIDED BY SOLICITOR - STEM IS A SUMMIT AND LOT NUMBER DE4AJ1000 IS NOT SHOWING ON JDE - HAS BEEN CONFIRMED THAT THERE ARE NO PRODUCT STICKERS AVAILABLE, LEFT AS UNKNOWN LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10966 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2969530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention