BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 3312196 · Received August 27, 2013

    Report

    Report Number
    1818910-2013-25290
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    September 26, 2008
    Report Date
    February 7, 2014
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2014 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND SIDE INFORMATION. DOR HAS BEEN IDENTIFIED AND WILL BE CORRECTED. PART/LOT FOR FEMORAL HEAD HAS BEEN IDENTIFIED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. COMPLAINT WAS UPDATED ON (B)(4) 2014. COMMENT: THERE IS A DOR DISCREPANCY BETWEEN LITIGATION AND THE PPD. DUE TO ACCURACY, THE DOR FROM THE PPD WILL BE REPORTED. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED.

    Description of Event or Problem · 1

    UPDATE - 08/22/2013-LEGAL CLAIM RECEIVED. FEMORAL HEAD HAS BEEN ADDED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419882 ASR UNI FEMORAL IMPL SIZE 55 TOTAL HIP IMPLANT KWA DEPUY INTL., LTD. - 8010379 2123432

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention