BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2151357 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11514
    Event Type
    Injury
    Date Received
    June 30, 2011
    Report Date
    May 31, 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
    TN, 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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, EXPLANT DATE, PMA/510(K) #, MANUFACTURE DATE. 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2007, PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJUR(IES) AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: PAIN AND SUFFERING (PAST AND FUTURE), MEDICAL EXPENSES, AND LOSS OF ENJOYMENT OF LIFE. IT IS FURTHER ALLEGED THE PT COULD NOT HAVE KNOWN THAT HE/SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE/SHE HAD HIS/HER BLOOD DRAWN AND HE/SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. PT HAS NOT YET SCHEDULE AN EXPLANTATION OF THE LEFT ASR HIP IMPLANT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6), 2007, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJUR(IES) AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: PAIN AND SUFFERING (PAST AND FUTURE), MEDICAL EXPENSES, AND LOSS OF ENJOYMENT OF LIFE. IT IS FURTHER ALLEGED THE PATIENT COULD NOT HAVE KNOWN THAT HE/SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE/SHE HAD HIS/HER BLOOD DRAWN AND HE/SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. PATIENT HAS NOT YET SCHEDULE AN EXPLANTATION OF THE LEFT ASR HIP IMPLANT. UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. THERE WAS NO INDICATION OF REASON FOR REVISION. PART AND LOT INFORMATION HAS BEEN PROVIDED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THIS INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2428975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention