BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2122759 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09750
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    March 17, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LEGAL CLAIM ALLEGES THE PATIENT UNDERWENT REVISION SURGERY. DOI: 2007 (BILATERAL) - DOR: (B)(6) 2008 (LEFT SIDE).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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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 INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LEGAL CLAIM ALLEGES THE PATIENT UNDERWENT REVISION SURGERY. UPDATE: (B)(6) 2011 - LITIGATION PAPERS ALLEGE SINCE THE SURGICAL IMPLANTATION OF THE ASR XL ACETABULAR SYSTEMS IN HER HIPS, PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO SWELLING, INFLAMMATION, GROIN PAIN, HIP PAIN, LOOSENING OF THE DEVICE, ELEVATED LEVELS OF METAL IONS AND PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS. AS A RESULT, ON OR ABOUT (B)(6), 2008, PATIENT REQUIRED SURGERY TO REMOVE THE ASR XL ACETABULAR SYSTEM FROM HER LEFT HIP AND REVISE IT WITH ANOTHER SYSTEM. PATIENT CONTINUES TO HAVE PROBLEMS WITH HER LEFT HIP EVEN AFTER REVISION.

    Description of Event or Problem · 1

    UPDATE - (B)(6) 2014 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. COMPLAINT UPDATED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 KWA KXA DEPUY INTERNATIONAL, LTD. NA 2429022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention