BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2832430 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-27794
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    February 25, 2014
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    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

    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

    LITIGATION PAPERS ALLEGE: PATIENT WAS REQUIRED TO LIVE WITH DEBILITATING PAIN AND ELEVATED BLOOD METAL LEVELS, AND SUFFER INHIBITIONS OF HIS ABILITY TO WALK. **UPDATE** (B)(4) 2012 - 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.

    Description of Event or Problem · 1

    UPDATE REC'D 05/27/2014 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR 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: 06/24/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2065522

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other