BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 46

    MDR report key: 2357444 · Received December 5, 2011

    Report

    Report Number
    1818910-2011-24896
    Event Type
    Injury
    Date Received
    December 5, 2011
    Report Date
    November 7, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 OR ABOUT (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE. PATIENT HAS EXPERIENCED PAIN AND DISCOMFORT IN HER RIGHT HIP. HER HEALTHCARE PROVIDER HAS ADVISED PATIENT OF THE NEED FOR A REVISION SURGERY. UPDATE: 11/11/2011 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO ELEVATED ION LEVELS AND METALLOSIS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE:ON OR ABOUT (B)(6), 2007, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE. PATIENT HAS EXPERIENCED PAIN AND DISCOMFORT IN HER RIGHT HIP. HER HEALTHCARE PROVIDER HAS ADVISED PATIENT OF THE NEED FOR A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2407764

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention