BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2151178 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11516
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    December 14, 2010
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY INTL., 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
    OTHER

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF STEM AND SLEEVE. UPDATE - (B)(6) 2011 - LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2008, PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURY(IES) AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: PAIN AND SUFFERING (PAST AND FUTURE), MEDICAL EXPENSES, LOSS OF ENJOYMENT OF LIFE AND LOST WAGES. 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. ACETABULAR CUP AND FEMORAL HEAD ARE BEING ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 87KWA KWA DEPUY INTL., LTD. NA 2663620

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention