BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3882323 · Received June 18, 2014

    Report

    Report Number
    1818910-2014-21461
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 4, 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
    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. REF. (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.

    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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO PAIN, ELEVATED METAL ION LEVELS, AND INFLAMMATION. UPON REVISION, LYMPHOCYTE MEDIATED REACTION, METAL-ON-METAL DEBRIS, TURBID-APPEARING FLUID, ONLY FIBROUS INGROWTH ON THE CUP AND WHITE TYPICAL REACTIVE TYPE FLUID WERE NOTED.

    Description of Event or Problem · 1

    UPDATE REC'D 01/27/2015- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES METALLOSIS AND SYNOVITIS. THE STEM AND SLEEVE ARE BEING ADDED BECAUSE OF ELEVATED METAL ION LEVELS. THE COMPLAINT WAS UPDATED ON: 02/03/2015.

    Description of Event or Problem · 1

    UPDATE REC'D 02/04/2015 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 02/09/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358271 ASR ACETABULAR CUPS 50 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2519128

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention