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What You Need to Know About a DuPuy Attune Implant Failure

Attune Lawsuit & Lawyer Information

Knee surgery replaces damaged knee joints and drastically reduces knee pain to help millions of people lead a more comfortable and independent life. It is estimated that 4.4 million living Americans have had some form of artificial knee implant surgery and the number of knee replacement systems that are implanted in patients is increasing in numbers. As a result, the number of reported complications that are connected with failed implants is increasing as well.

It is not uncommon to hear that knee implants fail and one of them that has received a lot of attention over the last few years is the DuPuy Synthes Attune Knee System. Manufactured by DuPuy Orthopaedics, this knee system has received several reports of patients having complications with this implant during various types of knee surgeries. If you have experienced DuPuy Synthes Attune knee replacement problems, you should know how to identify if your implant has failed and know your legal rights by staying informed on lawsuit information related to these implants.

What is the Attune Knee System?

Patients who undergo knee replacement surgery often require a knee implant. This implant will allow the patient to enjoy an improved range of motion and better stability. Overall, it helps people return to their normal activities so that they can continue to lead a normal life.

As a part of the largest research and development project in the company’s history, DuPuy Synthes introduced the Attune Knee System. This system was designed to improve function through stability and mobility of the knee joint and it was introduced to provide better results than older models of knee replacement systems. When it was introduced to the FDA for premarket approval in 2010, DuPuy Synthes submitted the system to the US Food and Drug Administration (FDA) claiming that the implant rivaled or was substantially equivalent to other knee system devices that were marketed during the same time.

DuPuy Orthopaedics

This company is widely known for its knee and hip replacement systems. As a part of the Johnson & Johnson family of companies, it offers the world’s most comprehensive portfolio of orthopedic and neuro products and services to include joint reconstruction for knee replacement surgeries.

Although the company is a leader in the medical device manufacturing field, it has been plagued with product recalls and patient lawsuits because of faulty implant designs and complaints from thousands of patients who received implants that caused further debilitating problems.

In 2013, the company recalled components of another knee implant device known as the Limb Preservation System. This system was reported to have premature failure as well as problems with loosening and fracturing. In 2010, DuPuy also recalled several hip devices which also had high failure rates.

Over the last few years, many artificial knee implant devices have been recalled and the reason is that is reported most commonly is that the implant does not attach or adhere to the bone properly. As a result, the failure of the knee implant causes not only significant pain but other serious problems for patients to include:

– Bone loss

– Infection

– Revision surgery

– Extensive rehabilitation

There was a recall issued by the FDA in June 2015 for a device manufactured by Attune called the Knee Tibial Articulation Surface Instrument after an investigation discovered that a small spring coil made of wire, which is used in the range of motion testing of the device during surgery, can become damaged or detached. This would sometimes happen prior to drilling holes for determining the proper tibial location for the implant. As a result, damage or detachment during surgery may allow the coil to remain in the patient if the surgeon does not know that the coil detached.

Common Problems with Knee Implants

It is typical for patients to experience a wide variety of problems after knee implant surgery. Some common ones include:

– Joint pain

– Swelling

– Nerve damage

– Joint instability

– Fractures of the surrounding bone

– Loosening or fracture of the device components

– Misalignment of implant components

– Device dislocation

If you have noticed any of the following symptoms in the months or years after receiving knee implant surgery, it is important to talk to your doctor soon as possible:

– Pain

– Stiffness

– Swelling around the knee joints

– Warmth

– Inflammation and redness

– Clicking and grinding sounds when walking

– Infection

– Decreased mobility

From 2003 to 2013, there was a total of 709 recalls that resulted from flaws and errors in the construction or design of failed implant devices made by the top six knee implant manufacturers in the world. 38% of these recalled knee implant devices belonged to DuPuy Synthes.

Original Replacement vs. Reconstructive or Revision Surgeries

Modern medical technology has advanced in such a way that total knee replacements can function without any problems or symptoms for up to 20 years. Many people have gotten satisfactory results from knee surgery and there are many patients who are happy with their decision to have knee replacement surgery.

On the other hand, there are times when implants fail prematurely and it is likely that the patient will require a painful revision surgery. The decision to undergo knee revision surgery is not easy because these types of surgeries are considered more invasive and painful than a first-time knee replacement. One of the reasons reconstructive or revision surgeries are more complicated and painful is because they usually require breaking the faulty device away from the bone. In other cases, the implant may be required to be cemented into place.

There are times when knee implants can damage the surrounding bone severely. When this occurs, reconstructive surgery is required before a replacement device can be installed. This is often required because the knee has to be completely rebuilt. These types of surgeries are also extremely painful for the patient and they usually have to go through long periods of rehabilitation.

In addition, reconstructive or revision surgeries also have a higher risk of infection because the patient is exposed. Other types of undesirable surgical complications include:

– Excessive bleeding

– Nerve or blood vessel damage

– Deep venous thrombosis

– Pulmonary embolism

DuPuy Synthes Attune Knee Replacement Problems

There have been several complaints from patients who have suffered severe side effects from DuPuy knee implants. Many of them experienced knee implant failure; particularly after having replacement surgery for the entire knee using the DuPuy Synthes Attune Knee System. The most common problem patients have reported are painful knee implant problems that occur after their Attune knee replacement devices fail within months of initial knee surgery. Others have reported premature failure after only a year or two of surgery.

Other reports include loosening of the Attune devices’ tibial base plate which leads to a variety of different complications to include pain, inflammation, infection, and injuries that include muscle or bone damage. Other reports state that these devices also have a loss or lack of bonding to the bone after the device fails which leads up to the patient needing additional surgeries or procedures.

When a knee replacement device prematurely fails, the most common reason (as noted by surgeons who performed reconstructive and revision surgeries) is that the device does not adhere to the bone properly because there is a lack of bonding between the implant and the bone. When this occurs, patients often face painful revision surgery, possible infection, and extensive rehabilitation. In addition, revision surgery is a lot more complicated than someone getting knee surgery for the first time. Complications become even worse when there is bone loss due to a faulty implanted device.

How Do You Know if Your Attune Knee Implant Failed?

If you or a loved one has an Attune implant, you will know it has failed when experiencing the following:

1. Persistent pain: If there is a constant throbbing of pain in your knee when it is in motion, there is a chance you could be suffering from a faulty implant.

2. Loosening or instability: When you stand up or put weight on your knee and you feel instability or your knee moves sideways or backwards in any manner, this may be a sign of a product that has failed. As ligaments become more damaged and inflamed, this condition could grow increasingly worse.

3. Heat or warmth in the knee: It is common to have heat or warmth in the knee for a few months after surgery because this is a normal sensation. However, if this heat or warmth continues to return, the cause could be an Attune knee implant that has failed.

4. Unusual swelling: Another indication that something could be failing with your knee implant is if there is a constant sensation of swelling. When the knee lining becomes inflamed, fluid will begin to build up which causes the swelling sensation.

The most common device failures listed in FDA complaints about Attune knee implant devices include:

– Components worn

– Loss or failure to bond

– Loss of osseointegration

– Fracture

– Metal shedding debris

Synthes Attune Lawsuit Information

If you or a loved one has had a DuPuy Attune knee implant replacement surgery and experienced problems or failures, an Attune lawsuit can provide you with some relief. It is not a good idea to wait for further advice from DuPuy Attune or the FDA before exploring your legal rights. You may be able to seek compensation for damages to include pain and suffering, medical bills, lost wages, and more.

Brake Issues Prompt BMW Recall

downloadAccording to the National Highway Traffic and Safety Administration, BMW is set to recall 76,000 of its vehicles. This recall pertains to the years 2012 through 2014 and includes various models.

What is the recall for?

The recall on BMWs has to due with a loss of power brake assist caused by an interruption of the oil supply to the vacuum pump, which operates the brake booster. The brake booster is what makes the power assist work.

What does this problem mean?

According to Matthew Russell, who is a spokesman for BMW, the brakes on the BMWs in question will still function. Matthew says the problem will only make it harder for the driver to press the brake pedal. However, this problem can cause stopping distances to grow as it will take more effort to stop the car.

What models are affected by the recall?

  • 2012 to 2014 328i and 320i and the 320i and 328i xDrive Sedan.

  • 2013-2014 328i xDrive Sports Wagon.

  • 2012-2013 528i and 528i xDrive Sedan.

  • 2013-2014 Xi sDrive28i and X1 xDrive28i.

  • 2013-2014 X3 xDrive28i.

  • 2012-2014 Z4 sDrive 2.81i.

How many vehicles has BMW had to recall of late?

Since 2010, there have been 306,000 vehicles recalled by BMW for various brake booster issues. They recalled around 30,000 of their X5 sport utility vehicles in February. This recall was issued due to the risk of oil contamination in the brake booster.

What type of BMW recall was this?

According to BMW, these recalls were voluntary and are only precautionary. However, it is stated that once a manufacturer is aware of an issue, it must inform the National Highway Traffic and Safety Administration within five business days or face fines.

What can we learn from recalls?

BMW is a luxury brand. However, even BMW has to issue recalls on their vehicles on occasion. These recalls just point out that there is no perfect vehicle design and virtually every vehicle will have its share of problems. Therefore, as consumers, it is wise to stay informed about recalls when they are issued.

 

 

Court Orders New Jury For $30 Million Tobacco Death Case

tobacco lawsuit updateThe ongoing case of a big tobacco manufacturer and a frail older woman continues as a Florida appeals court ordered that a second trial be conducted for the tobacco wrongful death lawsuit.

About the Case

The plaintiff in the case is an 80-year-old resident of Hollywood. She says that her husband started smoking when he was 13. In testimony and interviews, she also says that he could barely breathe for the final thirteen years of his life. He finally died at the age of 80 of chronic obstructive pulmonary disease in 2008. She sued R.J. Reynolds, the second largest tobacco company in the United States.

The Award

The woman originally won the case. The jury awarded her punitive damages in the amount of $25 million, along with $405,000 for medical and funeral expenses, and $4.83 million for pain and suffering.

Challenges to the Ruling

The Fourth District Court of Appeals made decisions regarding multiple matters. First it ruled that the Broward circuit court judge erred when he refused to allow the tobacco company to present part of its defense. In particular, the court ruled that the next jury should have an opportunity to hear the tobacco company’s defense regarding fraudulent concealment and conspiracy claims that were made against it.

The tobacco company says that the widow cannot prove that her husband relied on tobacco company fraudulent statements, which would keep the case within the 12-year statute of limitations against fraud. However, the court of appeals also ruled that the judge erred when he lowered part of the widow’s award. The circuit court judge had cut the punitive damages down to $15.7 million in a move that the court of appeals said was wrong because the amount was not “so excessive as to violate due process.”

What Next?

Because the case is going back for a new trial, the process essentially starts all over. The next jury may rule in favor of the window and award a larger or smaller verdict. It could also rule against the mother, and she could lose her chance at the verdict she received the first time around.

Vaginal Mesh Lawsuit Nearing Settlement

vaginal mesh discomfortManufacturers of Vaginal Mesh-Implants in Negotiations with Plaintiffs

Lawsuits relating to alleged injuries caused by vaginal mesh implants may be approaching settlement.

The manufacturers facing vaginal mesh lawsuits include C.R. Bard Inc., Endo Health Solutions Inc. (ENDP), Boston Scientific Corp. (BSX), Coloplast A/S (COLOB) and Cook Medical Inc. The products in question are vaginal mesh- implants which are inserted in order to support the muscles surrounding the pelvis to help prevent incontinence.  Reports indicate that one other company, Johnson & Johnson, is also facing similar legal problems but does not seem drawn in into the negotiations.

U.S. District Judge Joseph Goodwin Overseeing Vaginal Mesh Lawsuit

The federal-suits filed against the companies are under U.S. District Judge Joseph Goodwin in Charleston.  The plaintiffs have apparently requested for a settlement commission to be appointed. Goodwin has been reported to say that all parties involved are following settlement-protocols and want the issue settled as soon as possible.

The negotiations are intended to resolve about 30,000 implant-related suits set before Goodwin for discussion and settlement prior seeing to trial.

50,000 Claims Expected to be Filed

Reports indicate that the number of plaintiffs can still increase.  More people with similar complaints are allegedly set to file their claims too.  According to Carl Tobias, a professor of product liability law at University of Richmond, settlement seems the way to go as there seems to be no contest as to accountability.  The damages seem grave, the injured numerous, so the settlement may be in the multibillion dollar range.

Settlement Committee

The women who have filed the vaginal mesh lawsuits are reported to have requested Goodwin to include plaintiff counsels Garrard, Rice, Aylstock, and Clark so that negotiations with all the mesh –manufacturers can drawn up and finalized without delay.  The plaintiffs legal counsels face the difficulty of having to contend with more than fifty various implants made by six different manufacturers.  Some of these implants are no longer in the market while others still are.

 

Tobinco Recall Issued by the FDA for 100 Imported Drugs

tobinco recallThe FDA has issued a Tobinco recall. The Tobinco recall was ordered by the FDA because of 100 drugs distributed and imported by the company lacked proper authorization. While waiting for the recall, the authorities have started their investigations into how these drugs were imported into the country without approval and proper documentation.

James Lartey, the PR Officer of the FDA, said that the only places for the proper importation of drugs into the country were in Tema Port and Kotoka International Airport. The authorities have wondered how these assorted drugs got into the country without approval or documentation in the first place.

Tobinco Recall Updates

Aside from the lack of documentation and approval, it is more alarming that Tobinco’s drugs have been in the market for some time now. Mr. Lartey said that the authorities have already told its officials to do what it can to find, confiscate, and destroy the undocumented drugs that can harm public safety. The officials of the FDA would meet to make a decision and mete out sanctions on the company that is responsible for the importation and distribution of the undocumented drugs.

The Daily Graphic has reached out to the Western Regional Officer of the Food and Drug Administration, Solomon Agampim. Mr. Agampim told the Daily Graphic that the Drug Enforcement Department of the FDA has conducted surveillance on the surroundings of Tobinco Pharmaceuticals. The surveillance has revealed that Tobinco has 48 products that were not registered and approved by the FDA, while another 41 products had expired registrations. Upon further investigation, the FDA revealed that Tobinco’s 16 other drugs had pending registration and only two drugs were registered with the FDA.

The Decision of the FDA

Mr. Agampim has released a statement saying that it was unlawful for Tobinco to import and distribute drugs that are unregistered. It is not only a direct violation of the law, but it can potentially harm or kill innocent people. Tobinco was compelled to comply with the laws and regulations of the FDA regarding drugs. Also, Tobinco was compelled to dispose of the unregistered drugs safely at the expense of the company.

Mr. Agampim has also stated that the regional office of the FDA has been to the premises of Tobinco in Takoradi, and would move the consignment of the unregistered drugs to a landfill for proper and safe destruction. Tobinco has declined comment or interviews when contacted by the Daily Graphic.

 

 

Yet Another Stryker Recall Announced

stryker hip implant recallThe US FDA has posted a safety alert last August 29, 2013 informing the public of the class 1 recall of Stryker’s Oasys Midline Occiput Plate.

Reasons for recall

Stryker’s Oasys Midline Occiput Plate has been used in for cervical spinal fusion surgery. It has been used to stabilize the junction between the occipital bone and the vertebrae in the spinal cord.

However, Stryker has been receiving reports of post-operative problems with the said device. After orthopedic surgery, the pin that connects the tulip head to the plate body has a tendency to break.

Breakage of the pin can lead to destabilization of the plate and corrective surgery may be required to remove the fractured pin. The fracture of the pin may also lead to serious health hazards to patients including nerve injury and even blood loss.

Class 1 recall

Class 1 recall are the most serious type of recall that a product or device can receive. A class 1 recall means that a product has the probability of causing serious adverse health effects or even death to consumers and patients.

Recommendations to patients

The company is advising patients who have received the Oasys Midline Occiput Plate to observe for symptoms such as weakness, pain, or numbness. And if they do experience any of these symptoms, they should visit their doctor for urgent evaluation.

Meanwhile, patients who have already undergone revision surgery are advised to routinely receive post-operative care and follow-ups.

The FDA also encourages patients and healthcare professionals to immediately report any adverse effects connected to the product to FDA’s MedWatch Safety Information.

Background on the recall

Prior to the Class 1 recall issued by the FDA, Stryker already issued an Urgent Medical Device recall last May 2013 on its Oasys Midline Occiput Plate, advising medical facilities and healthcare institutions to immediately stop the use of the recalled lots.

Then by June 2013, Stryker had already alerted orthopedic surgeons to perform routine clinical and post-operative evaluation on patients implanted with the Oasys Midline Plate. They also recommended urgent evaluation for patients already experiencing symptoms such as pain or weakness.

Third Stryker recall

This has already been the third recall issued by Stryker on its medical devices. In 2007, the company recalled the Trident hip. While in 2012, Stryker also issued a recall of the Rejuvenate and ABG II models.

The recalls were issued following reports from patients of symptoms like pain, swelling, and even metal poisoning from the components after they were implanted with the devices.

Possible reasons for the multiple recalls

The multiple recalls on Stryker’s implants are, according to reports, due to the lack of proper testing of the devices. Stryker hip implants were only laboratory-tested before the implants were made available to the public.

Actos Lawsuit Update: Bellweather Pilot Programs (BPP)

biomet logoArtificial hip implant maker Biomet is facing a lawsuit against lead plaintiffs Leslie and Allison Caccia, who claim that the company’s M2A-Magnum artificial hip implant is defective. According to the plaintiffs, Mr. Caccia’s implant prematurely failed, produced metal poisoning, and forced him to undergo revision surgeries after the M2A-Magnum metal on-metal hip replacement system and ReCap Femoral Resurfacing System failed to take effect in his body.

This Actos lawsuit involves the BioMet M2A-Magnum hip implant, which is actually a metal-on-metal artificial hip replacement system that prevents premature hip failure. This is usually implanted to anyone that has developed metallosis or metal poisoning. Metallosis occurs when microscopic debris is released into the soft tissues of the body from these parts grinding upon one another; this can occur in daily activities such as standing, sitting, or walking. The

All product liability claims of the Biomet’s M2A-Magnum metal-on-metal hip replacement system have been requested by the company’s lawyers to be dismissed by the Caccias’ and other plaintiffs. Such a development in the Actos lawsuit has arisen according to the legal theory of federal preemption, which claims that implant makers are free from being sued for their design defects since the product is FDA approved.

But presiding Judge Robert L. Miller has denied this motion by Biomet’s lawyers despite the FDA approval using the investigational device exemption or IDE. IDE enables the testing f approved products in order to properly vouch for its safety and effectiveness. The IDE process show that the plaintiff’s ReCap System was done outside the proper controlled study and did not even include record keeping, FDA oversight or proper monitoring.

Judge Miller asserts his conviction on this matter, stating that he is not persuaded by Biomet obtaining the proper IDE status for the device; thus they are not exempt from the liability of using the device outside the necessary clinical trial.

Biomet is currently facing 600 cases under Judge Miller, which includes lawsuits pertaining to the Actos bellwether pilot programs. Injuries from the BioMet hip replacement system cover numerous victims from different parts of the country. Injury lawyers represent these individuals from various states, most of whom are experienced and knowledgeable on the action that needs to be done against medical issues. As more and more victims are coming forward, the awareness on the defect of Biomet’s products will eventually aid these people in moving forward and prevent others from making the same mistake when seeking treatment.