BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2213381 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15085
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 15, 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
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    LITIGATION PAPERS ALLEGE PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC LOSSES, DAMAGES, AND INJURIES AS FOLLOWS: PAST AND FUTURE MEDICAL AND RELATED EXPENSES AND COSTS; PAST AND FUTURE WAGE LOSS, AND LOSS OF EARNING CAPACITY/LOSS OF ABILITY TO EARN MONEY IN THE FUTURE; PAST AND FUTURE PHYSICAL PAIN AND SUFFERING; PAIN AND DISCOMFORT; DIFFICULTY AMBULATING; ANXIETY; FATIGUE; IRRITABILITY; ELEVATED CHROMIUM COBALT LEVELS; PAST AND FUTURE MENTAL PAIN AND ANGUISH; PAST AND FUTURE DISABILITY AND IMPAIRMENT; PAST AND FUTURE SCARRING AND DISFIGUREMENT; PAST AND FUTURE LOSS OF ENJOYMENT OF LIFE; LOSS OF SUPPORT AND SERVICES; ALL OTHER PAST FUTURE ECONOMIC LOSSES PERMITTED BY LAW; AND ALL OTHER PAST AND FUTURE NON-ECONOMIC DAMAGES PERMITTED BY LAW. IT IS ALSO ALLEGED PT'S INJURIES AND DAMAGES AND PERMANENT AND CONTINUING IN NATURE, AND PT WILL SUFFER SUCH LOSSES AND DAMAGES IN THE FUTURE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC LOSSES, DAMAGES, AND INJURIES AS FOLLOWS: PAST AND FUTURE MEDICAL AND RELATED EXPENSES AND COSTS; PAST AND FUTURE WAGE LOSS, AND LOSS OF EARNING CAPACITY/LOSS OF ABILITY TO EARN MONEY IN THE FUTURE; PAST AND FUTURE PHYSICAL PAIN AND SUFFERING; PAIN AND DISCOMFORT; DIFFICULTY AMBULATING; ANXIETY; FATIGUE; IRRITABILITY; ELEVATED CHROMIUM COBALT LEVELS; PAST AND FUTURE MENTAL PAIN AND ANGUISH; PAST AND FUTURE DISABILITY AND IMPAIRMENT; PAST AND FUTURE SCARRING AND DISFIGUREMENT; PAST AND FUTURE LOSS OF ENJOYMENT OF LIFE; LOSS OF SUPPORT AND SERVICES; ALL OTHER PAST AND FUTURE ECONOMIC LOSSES PERMITTED BY LAW; AND ALL OTHER PAST AND FUTURE NON-ECONOMIC DAMAGES PERMITTED BY LAW. IT IS ALSO ALLEGED PATIENTS INJURIES AND DAMAGES ARE PERMANENT AND CONTINUING IN NATURE, AND PATIENT WILL SUFFER SUCH LOSSES AND DAMAGES IN THE FUTURE. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2283732

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention