BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3895444 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21980
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    July 18, 2011
    Report Date
    January 20, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    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. 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

    NOTIFICATION THAT LITIGATION HAS BEEN FILED RECEIVED FROM LEGAL DEPARTMENT ON 3/26/2014. SPREADSHEET SHOWS LEGAL DEPARTMENT RECEIVED THIS INFORMATION ON 1/20/2014 AS PART OF THE SETTLEMENT REGISTRATION PROGRAM. UPDATE REC'D 12/22/2011: LITIGATION RECEIVED FROM LEGAL DEPARTMENT ON 6/2/2014 WITH A FILED DATE OF 12/22/2011. WE DO NOT HAVE RECORD OF RECEIVING THIS LITIGATION BEFORE 6/2/2014. LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370161 ASR ACETABULAR CUPS 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2229257

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention