BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2792593 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-76576
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    July 26, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    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 INFORMATION: DEPUY STILL CONSIDERS THIS INVESTIGATON 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.

    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 THAT THE PATIENT SUFFERED PAIN, STIFFNESS, DISCOMFORT, WEAKNESS; NEGATIVELY AFFECTING PATIENTS MOBILITY AND QUALITY OF LIFE, AND WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE 07/26/2013- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR AND DOB. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL 2965180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other