BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2800772 · Received October 22, 2012

    Report

    Report Number
    1818910-2012-76719
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    August 17, 2012
    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. (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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT'S ACETABULAR CUP DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS AND/OR LOOSENED FROM THE PATIENT'S ACETABULUM, CAUSED SEVERE PAIN AND INHIBITED PATIENT'S ABILITY TO WALK. UPDATE: (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND DATE OF IMPLANT. 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 ALLEGES THAT THE PATIENTS ACETABULAR CUP DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS AND/OR LOOSENED FROM THE PATIENTS ACETABULUM, CAUSED SEVERE PAIN AND INHIBITED PATIENTS ABILITY TO WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2647782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other