BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 43

    MDR report key: 3895607 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-22010
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    February 5, 2014
    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
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-(B)(4). INVESTIGATION SUMMARY ==> THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6)2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL- LEFT; REASON(S) FOR REVISION: PAIN, METALLOSIS, HIGH METAL ION LEVEL IN BLOOD, ULTRASOUND SHOWS COPIOUS EFFUSION.

    Description of Event or Problem · 1

    ASR REVISION ASR XL- LEFT REASON(S) FOR REVISION: PAIN, METALOSIS, HIGH METAL ION LEVEL IN BLOOD, ULTRASOUND SHOWS COPIOUS EFFUSION UPDATE 23 MAR 2018. ADDITIONAL INFORMATION RECEIVED FROM (B)(6). AS PER REVIEW OF THE NEW INFORMATION THERE IS NO UPDATE TO THE PC. DOI: (B)(6)2006; DOR: (B)(6)2014; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371522 DEPUY ASR XL FEM IMP SIZE 43 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD - 8010379 2195125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention