BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2121920 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-10066
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    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

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON (B)(6), 2006, PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE. IN 2009, PT EXPERIENCED INCREASING PAIN IN HER LEFT HIP. SHE WAS HAVING DIFFICULTY WITH HER MOVEMENT AND BALANCE. HER SLEEP WAS DISRUPTED AND CONTINUES TO BE DISRUPTED BY THE LEFT HIP DISCOMFORT. PRESENTLY, PT STILL EXPERIENCES PAIN IN HER LEFT HIP AND PAIN IN HER LEFT LEG AND FOOT. SHE HAS LOST MOBILITY. IN ADDITION, THE LEFT HIP MAKES A GRINDING AND POPPING SOUND UPON MOVEMENT. RECENT BLOOD TESTS HAVE REVEALED ELEVATED CHROMIUM LEVELS IN HER BLOOD STREAM. ADDITIONALLY, IT IS ALLEGED THAT PT WILL REQUIRE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2180778

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention