BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2231775 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17015
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 3, 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

    (B)(4).

    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)(4) 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) 2007, PATIENT HAD THE DEPUY ASR HIP IMPLANTED INTO HER LEFT SIDE. SINCE HAVING THE ASR IMPLANTED, PATIENT HAS SUFFERED EXTREME PAIN IN HER HIP, CAUSING DIFFICULTY AMBULATING AND SLEEPING. SHE WILL BE REQUIRED TO UNDERGO REVISION SURGERY. UPDATE: (B)(6) 2011 - PATIENT WAS REVISED. REASON FOR REVISION WAS NOT PROVIDED. UPDATE: (B)(6) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. MEDICAL RECORDS WERE ALSO RECEIVED, WHICH NOTED METALLOSIS. 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: ON (B)(6), 2007, PATIENT HAD THE DEPUY ASR HIP IMPLANTED INTO HER LEFT SIDE. SINCE HAVING THE ASR IMPLANTED, PATIENT HAS SUFFERED EXTREME PAIN IN HER HIP, CAUSING DIFFICULTY AMBULATING AND SLEEPING. SHE WILL BE REQUIRED TO UNDERGO REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2338698

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention