BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2142882 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11147
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION EVENT DESCRIPTION, DATE OF EXPLANT. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT SIDE ON OR ABOUT (B)(6), 2009. AFTER HIS SURGERY, PT EXPERIENCED PAIN AND DISCOMFORT IN HIS LEFT HIP, METALLOSIS EXPOSURE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PT HAS NOT YET SCHEDULED A REVISION SURGERY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT SIDE ON OR ABOUT (B)(6) 2009. AFTER HIS SURGERY, PATIENT EXPERIENCED PAIN AND DISCOMFORT IN HIS LEFT HIP, METALLOSIS EXPOSURE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A REVISION SURGERY. UPDATE: (B)(4) 2011 - 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

    UPDATE 5/7/2013 - MEDICAL DEVICE DECLARATION FORM WAS RECEIVED STATING THE DOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2706182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention