BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3924495 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23069
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    August 20, 2014
    Report Date
    January 9, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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.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

    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

    LITIGATION ALLEGES PAIN, ELEVATED METAL ION LEVELS, AND BROWN FLUID IN AN ASPIRATION. PPD ALSO RECEIVED.

    Description of Event or Problem · 1

    UPDATE REC'D 01/09/2015 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR INFORMATION. THE STEM AND ADAPTER SLEEVE ARE BEING ADDED BECAUSE OF ELEVATED METAL ION LEVELS. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THE COMPLAINT WAS UPDATED ON: 01/22/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404271 ASR ACETABULAR CUPS 54 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2238213

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other