BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 2232457 · Received September 2, 2011

    Report

    Report Number
    1818910-2011-17153
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    November 10, 2011
    Report Date
    June 1, 2012
    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

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE (B)(4) WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 2010, AND THE (B)(4) 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: IN (B)(6) 2009 AND (B)(6) 2010, BILATERAL PATIENT WAS IMPLANTED WITH DEPUY ASR HIPS ON BOTH HER LEFT AND RIGHT SIDES. IN THE MONTHS FOLLOWING HER SURGERIES, PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIP. IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, AND TO RISE FROM A SEATED POSITION. ON (B)(6) 2010, PATIENT UNDERWENT REVISION SURGERY ON HER RIGHT SIDE. A REVISION SURGERY FOR HER LEFT HIP WILL BE CONDUCTED IN 2011.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, DATE OF IMPLANTATION AND REVISION FOR BOTH SIDES. 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 41 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2723542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention