BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2250198 · Received September 15, 2011

    Report

    Report Number
    1818910-2011-18270
    Event Type
    Injury
    Date Received
    September 15, 2011
    Report Date
    August 17, 2011
    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

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED INJURIES, INCLUDING EXTREME PAIN AND ELEVATED METAL ION DEBRIS AND THE LIKELY NEED FOR A REVISION SURGERY, AND OTHER INJURIES PRESENTLY UNKNOWN. UPDATE: (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED INJURIES, INCLUDING EXTREME PAIN AND ELEVATED METAL ION DEBRIS AND THE LIKELY NEED FOR A REVISION SURGERY, AND OTHER INJURIES PRESENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 HIP KWA DEPUY INTERNATIONAL 2565661

    Patients

    Seq Age Sex Outcome Treatment
    1