BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-HIP

    MDR report key: 2874443 · Received December 14, 2012

    Report

    Report Number
    1818910-2012-28801
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    February 19, 2010
    Report Date
    March 31, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    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. PLAINTIFFS¿ COUNSEL ADVISED ON 1/17/14 THAT THE FOLLOWING PLAINTIFFS DID NOT RECEIVE AN ASR IMPLANT. PLAINTIFFS¿ COUNSEL PLANS TO DISMISS THE CASES. ONCE THE DISMISSALS ARE FILED, WE WILL FORWARD THEM TO YOUR ATTENTION.

    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. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. AS THE CASE IS IN LITIGATION, FOLLOW UP FOR THIS ADDITIONAL INFORMATION WILL BE PERFORMED BY DEPUY LEGAL. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT SINCE THE SURGICAL IMPLANTATION OF THE ASR SYSTEM, THE PATIENT HAS EXPERIENCED PAIN AND DISCOMFORT IN HER HIP. AS A RESULT THE PATIENT UNDERWENT REVISION SURGERY, BUT CONTINUES TO EXPERIENCE PAIN IN HER LEFT HIP. IT IS ALSO ALLEGED, THAT THE PATIENT HAS SUFFERED PERMANENT INJURIES AS A RESULT OF THE IMPLANTATION OF ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK-HIP UNIDENTIFIED HIP IMPLANT OR INSTRUMENT KXA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention