BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 52

    MDR report key: 2211719 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-15420
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    June 15, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES :PATIENT WAS REVISED DUE TO PAIN, TIGHTNESS AND A HEMATOMA. DOI: (B)(6) 2009; DOR: (B)(6) 2009 (RIGHT SIDE). BILATERAL PATIENT - LEFT SIDE REPORTED IN SEPARATE COMPLAINT. **UPDATE - (B)(6) 2011 - 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 COLLECTED 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. ASR CUP - DOI: (B)(6) 2009; DOR: NONE REPORTED (RIGHT SIDE). ASR FEMORAL HEAD - DOI: (B)(6) 2009; DOR: NONE REPORTED (RIGHT SIDE). (B)(6). TE 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

    PATIENT WAS REVISED DUE TO PAIN, TIGHTNESS AND A HEMATOMA. BILATERAL PATIENT - LEFT SIDE REPORTED IN SEPARATE COMPLAINT. UPDATE (B)(6) 2011 - LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 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 COLLECTED 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
    1 ASR 300 SPIKED CUP SIZE 52 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2815289

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention