BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 2230255 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17007
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 14, 2026
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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: ON (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER LEFT SIDE. IN THE YEARS FOLLOWING HER SURGERY, 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. PATIENT WAS REVISED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HEAD TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention