DePuy Orthopaedics, Inc., announced it is voluntarily recalling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a second hip replacement procedure, called a revision surgery.
The majority of ASR hip replacement surgeries have been successful. However, the company is advising patients with an ASR device to visit their surgeons for evaluation of their implant performance. Yearly monitoring is recommended to ensure the ASR hip replacement is functioning well, even in the absence of symptoms.
New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12% for the ASR™ Hip Resurfacing System and approximately 13% for the ASR™ XL Acetabular System. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients. Previous post-market surveillance data from a variety of sources – including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports – had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.
DePuy intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR.
DePuy is providing hospitals, surgeons and patients with comprehensive information about the recall to help them determine next steps. Patients and health care professionals with questions related to this recall should visit depuy.com. As of August 27, patients in the U.S. and Canada can contact DePuy by calling 888-627-2677 Monday-Saturday, 8 a.m. to 9 p.m. EST. Patients in other countries can place a collect call to the U.S. at +1 813-287-1651 24 hours a day, seven days a week.
The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide.
Very few devices remain on the worldwide market. DePuy decided in 2009 that it would be discontinuing the ASR System as a result of declining demand and the intention to focus on the development of next generation hip replacement and resurfacing technologies that best meet the needs of surgeons and patients.
DePuy has notified the U.S. Food and Drug Administration and other regulatory agencies globally of the voluntary recall.
At approximately 9:30 am Thursday September 2, 2010, a helicopter company reported a blast in the Gulf of Mexico. The oil rig exploded less than 100 miles to the south of Vermillion Bay. This oil rig blast site is also west of the BP Deepwater Horizon blast site. Information currently available indicated that several aircraft and boats were proceeding to the oil rig blast site.
Reports indicate that all thirteen people working on the rig have been accounted for. It appears that the rig is still on fire. Additional information was not yet available. As information is received regarding this explosion, we will update our website. Please check back frequently.
Emerging news reports from the Times Picayune are now reporting that the rig was ”an oil and gas production rig located in 340 feet of water.” Additionally, the article indicated one injury has been reported and “twelve of the workers are in immersion suits, designed to protect them from hypothermia.”
A tragic accident happened early this morning in Scotland, Arkansas. Three members of a medical helicopter team tragically lost their lives when the helicopter crashed. At the time, only medical crew members were in-flight. This accident is under investiation.
According to The Associated Press, “Federal Aviation Administration spokesman Lynn Lunsford says the Air Evac helicopter crashed at about 4:15 a.m. Tuesday near the Scotland community in Van Buren County.”
As further details emerge we will update this blog.
A wooden toy rattle made by P. Graham Dunn of Dalton, Ohio was recently recalled because it poses a choking hazard to children.
The rattle is composed of an outer ring of wooden dowels which encase a small metal rattle. If the wooden dowels become lose or displaced, the metal rattle becomes easily accessible to children. Although no injuries have been reported, four broken rattles have been reported so far.
In all, 500 units of this rattle, which was made in China are being recalled. The rattle was sold for $6.00 between June and July 2010.
The small circular rattle is 2 and ¾ inches in diameter and consists of eight wooden dowels. It consists of two circular light brown wooden discs on the top and bottom connected by the dowels.
Mississippi exhibited a proactive approach to dealing with the Gulf Oil Spill. After the Deepwater Horizon Oil Rig exploded, the Gulf water was saturated with oil. This oil has impacted the livelihood of individuals in the oil industry, businesses and proprietors of the Gulf Seafood industry, and many other individuals. Louisiana, Mississippi, Alabama, Florida, and Texas have a mess on their hands. Now they are cleaning it up.
Governor Haley Barbour of Mississippi appointed a 38 person commission to deal with Mississippi’s oil dilemma. Seeking long-term recovery as opposed to short-term solutions, the Governor has accumulated a highly knowledgeable team of researchers, business experts, and industry specialists.
Jay Grimes with the University of Southern Mississippi’s Gulf Coast Research Lab was quoted by Gulf Live as stating:
“My concern is what is the fate and effects of the oil in Mississippi. I feel, and my colleagues at the lab agree, that we need to take a look at the toxicity of the oil and of the dispersed oil. We need to test the immediate toxicity and the long-term toxicity’s effect on all forms of marine life.”
Other individuals who will also serve on the committee include Co-Chairs William Walker (Mississippi Department of Marine Resources) and Trudy Fisher (Mississippi DEQ) as well as Tom Becker, of the Mississippi Gulf Coast Charter Boats Association; LaDon Swann, director of the Mississippi-Alabama Sea Grant Consortium; Ron Peresich, chairman of the Gulf Coast Business Council; Jerry St. Pé, Jackson County businessman; Chuck Benvenutti, Hancock County businessman; Steve Renfroe, of Chevron’s Pascagoula refinery; and Sen. Tommy Moffatt; and others.
Gulf Live quoted the governor as saying:
“In the wake of the oil spill, we have an opportunity to address any number of issues in a comprehensive way, not just for right now, but into the future…This commission will have a wide charge, from preliminarily determining the impact of the oil spill on Gulf ecosystems to addressing concerns about seafood safety to improving hurricane protection and habitat restoration.”
Fisher Price of East Aurora, New York, in conjunction with the U.S. Consumer Product Safety Commission and Health Canada issued a voluntary recall for its Little People Play ‘n Go Campsite on August 5, 2010.
The recalled toy is a seven piece set which includes a pink plastic tent with carrying handle, a plastic rabbit, a pink plastic chair with a floral seat design, plastic marshmallows on a stick, a plastic campfire ring, and a small plastic doll.
The doll, known as Sonya Lee, can come apart at the waist. When this happens, small parts of the dollar are easily accessible. These parts constitute a possible choking hazard for young children.
The toy’s product number is R6935 and was manufactured in China. This particular Fisher Price toy was sold nationwide for approximately $15.00. No other Sonya Lee plastic dolls have been recalled.
In all, 96,000 U.S. units are involved in the recall. 14,000 Canadian units have also been implicated. With the exception of the Sonya Lee doll, all other pieces of the playset are not recalled. Sonya Lee’s name is imprinted on the figure itself.
Attorney Richard J. Arsenault, of Neblett, Beard, and Arsenault in Alexandria, Louisiana was recently named to the 2011 Edition of Best Lawyers in America.
Best Lawyers in America is a highly regarded publication listing exceptional attorneys throughout the country. The distinction is based upon a peer-review system with input from over three million attorneys. The American Lawyer has described the Best Lawyers publication as “the most respected referral list of attorneys in practice.” List exerts are posted in The Washington Post, The Los Angeles Times, and New York Magazine. Best Lawyers in America also recently joined with U.S. News & World Report by adding a Best Lawyers Search Engine on the U.S. News website.
Arsenault’s legal career spans more than thirty years, and he has frequently been recognized for his contributions as both a litigator and published author. In addition, Arsenault serves as an instructor with Louisiana State University Law School’s Trial Advocacy Program.
Arsenault has been selected for inclusion in Bar Register of Preeminent Lawyers, American Trial Lawyer’s Association’s Top 100 Trial Lawyers, Louisiana Super Lawyers, Best of the United States and currently holds an AV Rating from Martindale-Hubbell, the highest rating available. His legal expertise has been featured by the National Law Journal, Associated Press, the Wall Street Journal, the New York Times, CBS, Business Week, NPR, the London Times and BBC.
Neblett, Beard, and Arsenault would like to extend congratulations to Mr. Arsenault for this outstanding honor.
According to a press release sent by the Louisiana Department of Health and Hospitals (DHH), it is believed that 334 people have been made ill or have suffered injuries due to the Gulf of Mexico oil spill and its clean up efforts. Of those sickened, 221 were working on oil rigs or were involved in the clean up efforts. The remaining 84 are members of the general public. Of the workers, 17 required hospitalization.
In its recent Oil Spill Surveillance Summary report, the DHH indicated that the most common complaints included exposure to odors/fumes, skin contact with contaminated water or objects, heat stress and lacerations/fractures associated with the clean-up and containment efforts. The illnesses and injuries were reported to hospital emergency departments, outpatient clinics, physicians’ offices and the Louisiana Poison Center. These cases were monitored by the DHH’s Office of Public Health and Section on Environmental Epidemiology & Toxicology. The most frequently reported symptoms were headache, dizziness, neaseau, vomiting, weakness/fatigue and upper respiratory irration.
While it looks the the devastating oil leak will finally be stopped permanently, residents of the Gulf Coast are just now starting to see the long-term effects associated with this environmental disaster. It is troubling to see the effects of the oil spill on our coast, waters, wildlife, human health and way of life. We will continue to follow this story, so stay tuned.
The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Baby Matters LLC, of Berwyn, Pa., is announcing the voluntary recall of 30,000 Nap Nanny® portable baby recliners. CPSC is investigating a report of a 4-month-old girl from Royal Oak, Mich. who died in a Nap Nanny® that was being used in a crib. According to preliminary reports, the infant was in her harness and found hanging over the side of the product, caught between the Nap Nanny® and the crib bumper.
CPSC and Baby Matters are aware of one other incident in which an infant became entrapped when the Nap Nanny was used in a crib, contrary to the product instructions. In that incident, the infant fell over the side of the Nap Nanny®, despite being harnessed in, and was caught between the baby recliner and the side of the crib. The infant sustained a cut to the forehead.
CPSC and the firm have received 22 reports of infants, primarily younger than 5-months-old, hanging or falling out over the side of the Nap Nanny® despite most of the infants being placed in the harness. One infant received a bruise as a result of hanging over the side of the product.
Infants can partially fall or hang over the side of the Nap Nanny® even while the harness is in use. This situation can be worse if the Velcro™ straps, located inside the Nap Nanny® cover are not properly attached to the “D”-rings located on the foam, or if consumers are using the first generation model Nap Nanny® that was sold without “D”-rings.
In addition, if the Nap Nanny® is placed inside a crib, play yard or other confined area, which is not a recommended use, the infant can fall or hang over of the side of the Nap Nanny® and become entrapped between the crib side and the Nap Nanny® and suffocate.
Likewise, if the Nap Nanny® is placed on a table, countertop, or other elevated surface and a child falls over the side, it poses a risk of serious head injury. Consumers should always use the Nap Nanny® on the floor away from any other products.
The Nap Nanny® is a portable recliner designed for sleeping, resting and playing. The recliner includes a foam base with an inclined indentation for the infant to sit in and a fitted fabric cover and a three point harness. The first generation model of the Nap Nanny® can be identified by the absence of “D”-rings in the foam base. In second generation models, the harness system has “D”-rings in the foam base and Velcro™ straps inside the fitted fabric cover.
The recalled Nap Nannys® were sold at toy and children’s retail stores nationwide and online, from January 2009 through July 2010 for about $130.
The recalled product was manufactured in the United States and China.
Consumers with a first generation Nap Nanny® models, without “D”-rings, should stop using the recalled baby recliners immediately and contact the firm to receive an $80 coupon towards the purchase of a new Nap Nanny® with free shipping. Consumers with a second generation Nap Nanny® model, with “D”-rings, should immediately stop using the product until they are able to visit the firm’s website to obtain new product instructions and warnings. Consumers will also view an important instructional video to help consumers ensure the harness is properly fastened. Consumers who are unable to view the video or new instructions online, should contact the firm to receive free copies by mail. For more information, contact Baby Matters toll-free at (888) 240-4282 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the firm’s website.
Four people from died after an 18 wheeler lost control, crossed the median and slammed head on into their pickup, Louisiana State Police said.
The 18-wheeler, marked with the company name Texas International Express LLC, was traveling north about 5 miles north of Pearl River when its front left tire blew out, said Trooper Nick Manale, spokesman for State Police Troop L. The driver, Juan Torres, 37, of Montgomery, Texas, lost control of the rig, and the tractor-trailer rumbled across the median and struck the southbound pickup nearly head-on, police said. After impact, the pickup and 18-wheeler slid off the highway, coming to a halt in the treeline on the west side of the interstate, Manale said.
Troopers specializing in vehicle inspection were brought in to determine whether the 18-wheeler had all of the required equipment and whether that equipment was properly installed, police said. Federal Motor Carrier SafetyRegulations require an 18-wheeler driver to perform a pre-trip inspection and a end of the day report. A driver cannot operate a commercial motor vehicle until he has inspected his equipment including the tires for good working order.
§392.7 Equipment, inspection and use.
No commercial motor vehicle shall be driven unless the driver is satisfied that the following parts and accessories are in good working order, nor shall any driver fail to use or make use of such parts and accessories when and as needed:
Service brakes, including trailer brake connections.
Parking (hand) brake.
Steering mechanism.
Lighting devices and reflectors.
Tires.
Horn.
Windshield wiper or wipers.
Rear-vision mirror or mirrors.
Coupling devices.
[33 FR 19732, Dec. 25, 1968, as amended at 60 FR 38746, July 28, 1995]
