BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2231656 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17011
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    May 14, 2008
    Report Date
    March 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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

    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

    PATIENT WAS REVISED TO ADDRESS A LOOSE ASR CUP (LEFT SIDE). **UPDATE**-(B)(6) 2011 - LITIGATION PAPERS RECEIVED. THEY ALLEGE THAT PATIENT EXPERIENCED HIGH LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

    Description of Event or Problem · 1

    UPDATE 03/27/2014 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PAIN. UPON REVISION, FLUID WAS NOTED. THE COMPLAINT AND ASSOCIATED MDR'S WERE UPDATED. THE INFORMATION RECEIVED DOES NOT AFFECT THE MDR DECISION. COMPLAINT WAS UPDATED ON 04/21/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL IMPLANT KWA DEPUY INTERNATIONAL 2513723

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention