BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 3170804 · Received June 14, 2013

    Report

    Report Number
    1818910-2013-03186
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    August 27, 2014
    Report Date
    November 25, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. REF. (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.DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT EXPERIENCED PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, HIGH LEVELS OF TOXIC METAL IN BLOOD STREAM, AND SUFFERING. PATIENT HAS NOT BEEN REVISED. UPDATE: (B)(6) 2012: PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Description of Event or Problem · 1

    UPDATE REC¿D 11/25/2014 - PPD WITH MEDICAL RECORDS RECEIVED. UPON REVISION, INFLAMMATION, BROWN STAINING OF THE BURSA, METALLOSIS, BROWN STAINED FLUID, AND OSTEOLYSIS WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT FOR ELEVATED METAL ION LEVELS. THE STEM REMAINED IN SITU. THIS COMPLAINT WAS UPDATED ON: 12/22/14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272015 ASR UNI FEMORAL IMPL SIZE 55 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2199353

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other