BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3103485 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-04433
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    January 10, 2012
    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
    VA, US
    Reporter Occupation
    ATTORNEY

    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. REF. (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 THE LATE SUMMER OR FALL OF 2009 AND THEREAFTER, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT: PAIN IN THE BOTTOM OF HER FOOT, ON THE SECOND TOE OF HER RIGHT FOOT, RIGHT KNEE PAIN SWELLING IN HER RIGHT CALF, LOWER LEG AND ANKLE AREA, TIGHTNESS IN ABDUCTOR REGION OF RIGHT LOWER EXTREMITY, TIGHTNESS IN BOTH HIPS, BILATERAL THIGH DISCOMFORT, DECREASED SENSATION ON THE RIGHT BIG TOE MEDIAL ASPECT AND MEDIAL ASPECT OF THE RIGHT FOOT. IT IS ALSO ALLEGED TESTING OF THE BLOOD OF PATIENT COLLETED ON (B)(6) 2010, DEMONSTRATED HIGH CHROMIUM BLOOD LEVELS OF 5.7 NG/ML AND HIGH COBALT BLOOD LEVELS OF 19.6 NG/ML. IT IS FURTHER ALLEGED TESTING OF THE BLOOD OF PATIENT COLLECTED ON (B)(6) 2011, DEMONSTRATED HIGH CHROMIUM BLOOD LEVELS OF 10 NG/ML AND HIGH COBALT BLOOD LEVELS OF 49 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202883 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2775334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other