BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASR SLEEVE

    MDR report key: 6034791 · Received October 17, 2016

    Report

    Report Number
    1818910-2016-29697
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    December 2, 2015
    Report Date
    September 26, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDG
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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, 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

    LITIGATION DOCUMENTS RECEIVED. LITIGATION ALLEGES THAT PATIENT WAS REVISED TO ADDRESS PAIN, METALLOSIS, NOISE (CLICKING) AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686364 UNKNOWN ASR SLEEVE HIP FEMORAL STEM/SLEEVE JDG DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention