Several Zimmer Artificial Knee Implants Recalled

In December 2010, the FDA announced a recall by joint implant manufacturer Zimmer Inc. of the NexGen Complete Knee Solution LPS Femoral Components. The devices were shown to exhibit a nonconforming internal CAM radius, although not every device was believed to be defective.

In September 2010, a recall was issued for the NexGen Complete Knee Solution MIS Tibial Components. This device was recalled after receiving complaints of loosening that often resulted in patients undergoing painful and expensive revision surgeries.

Rights of Victims

The failure of certain Zimmer artificial joint devices can cause symptoms such as pain, looseness, instability and swelling at the site of the implant, and can ultimately lead to revision surgery. Revision surgery is costly and painful. Recovery takes at least as long as the original surgery, and for many people, this means a detrimental loss of income, on top of extensive hospital bills. Patients who have suffered early device failure, especially that which leads to revision surgery, deserve compensation for the associated physical, financial and emotional losses. Compensation can be obtained by filing a claim against Zimmer with the help of one of the experienced and aggressive personal injury attorneys of Oshman & Mirisola.

Research Discovers Additional Zimmer Implant Failure

As part of the mounting public scrutiny over under-regulated medical devices, prominent medical experts have expressed grave concern over the serious risks associated with another popular Zimmer knee implant device: NexGen CR-Flex. The NexGen CR-Flex Knee Implant is intended for total knee replacement.

Some doctors have found that the porous non-cement femoral component of the device (the part that covers the head of the femur or thigh bone) is prone to high failure rates. Two renowned Chicago orthopedic surgeons—Richard Berger and Craig Della Valle from Rush University Medical Center—argue that Zimmer’s NexGen CR-Flex Knee Replacement devices should not be used on any patient, given their high risk of failure and serious side effects.

It was increasing concern over the NexGen CR-Flex that prompted Berger, a former Zimmer consultant, and Della Valle to conduct research on the implant. The study found that within two years of Zimmer NexGen CR-Flex knee implantation, 36 percent of the implants of study participants were loose and more than 8 percent required revision surgery due to looseness and serious pain. Dr. Berger describes this failure rate as “horrific.”

MDL Consolidation Strengthens Lawsuits Against Zimmer

Those involved with suits against Zimmer regarding certain NexGen knee replacement products have won the right to have their actions consolidated into an MDL (multidistrict litigation). This was an important step for those who have filed claims and those who are considering filing. Now the MDL plaintiff steering committee can help these clients and their cases by working together and sharing information to build a stronger attack against Zimmer.

Have You Been Injured by an Artificial Joint Made by Zimmer?

If you or a loved one has received a failing Zimmer NexGen knee replacement device, you may have a legal case against Zimmer. Please contact the qualified and skilled medical device attorneys of Oshman & Mirisola who will listen to your story and determine the best way to help you receive compensation for medical expenses and lost income, as well as your physical and emotional suffering.

Lack of Safety Testing on Medical Devices in US

According to a New York Times report, US orthopedic medical device makers are not required to submit safety data prior to FDA approval if a similar device has already been approved, making it difficult to determine the true safety of each medical device on the market today. This questionable process, known as 510(k) approval, is considered outdated and unsafe by many experts in the medical device field. As the news report attests, “those with the most to lose [from this lack of safety testing and reporting] are the hundreds of thousands of people who receive an orthopedic device each year.”

On January 13, 2011 the Food and Drug Administration (FDA) lowered the limit of acetaminophen allowed to be included in prescription drugs to only 325 milligrams per dose. The FDA also mandated an update to labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury. There is a wide array of both prescription and over the counter drugs that include acetaminophen (see list of drugs at the bottom of this page) and prior to this new limit, many of the prescription medications had up to 750 milligrams of acetaminophen per dose. The FDA also now proposes inclusion of their most severe “Black Box” warning on all prescription products that contain acetaminophen.

Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER) said, “FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

TAKING MORE ACETAMINOPHEN THAN YOU KNOW. WHAT IS APAP?

“APAP” is an abbreviation for acetaminophen that many drug-makers use as shorthand in the list of ingredients on their drug packaging. Even if the prior dosage of acetaminophen had been an appropriate amount, it is not uncommon for users to accidentally exceed recommended dosage limits by taking more than one medication that includes acetaminophen at a time without realizing it because they do not recognize that “APAP” is, in fact, also acetaminophen! Some of the most popular drugs that use the abbreviation “APAP” are Percocet, Vicodin, and Tylenol with Codeine, among others.

WHAT IS ACETAMINOPHEN?

Acetaminophen was approved by the United States Food and Drug Administration (FDA) in 1951. Acetaminophen, known as Paracetamol internationally, is a pain reliever and fever reducer. Acetaminophen is most commonly sold under the brand Tylenol, but it is an ingredient in hundreds of brands both prescription and over the counter (OTC). It is frequently found in cold and flu medications. Acetaminophen has been linked to liver damage and failure.

ACETAMINOPHEN LIVER DAMAGE/FAILURE

While there are claims of Acetaminophen’s general safety at recommended doses, acute overdoses can cause potentially fatal liver damage. There is also a chance for some users that a normal dose can carry the same risk. The liver is responsible for metabolizing drugs, so once toxic levels of acetaminophen occur in the liver, the natural antioxidant defenses of the body are overwhelmed. When this happens, the liver is damaged by the buildup of dangerous toxins. Scientists at the University of North Carolina, Chapel Hill recently conducted a study, now published in the Journal of the American Medical Association, that showed that in some cases 44% of participants who took acetaminophen, either alone or in combination with another drug, over a two week time frame, showed abnormal elevations of a liver enzyme that is known to be a precursor to liver damage.

Paracetamol toxicity is the leading cause of liver failure. Acetaminophen is to blame for the majority of drug overdoses in the United States. More than 30,000 cases of Acetaminophen overdose are reported per year, according to the American Association of Poison Control Centers. Overdoses of Acetaminophen can lead to liver failure, which requires treatment or can necessitate a liver transplant. Liver failure that necessitates a liver transplant is particularly devastating. Thousands of people in the United States are currently waiting for livers. A liver transplant is also one of the most expensive procedures in modern medicine. If left untreated, liver failure can result in death.

So adverse were the potential health risks of Acetaminophen that even before the recent change in dosage to prescriptions drugs containing acetaminophen noted above, the FDA advisory committee recommended restrictions to lower the maximum dosage and put warnings on the labels of over the counter drugs containing Acetaminophen in 2009. The FDA’s concern is that the former recommended maximum dose was shown to produce alterations in hepatic (liver) function. Unfortunately the many manufactures of prescription drugs containing Acetaminophen have three years to alter the amount in their products, so there are still drugs on the market with suggested maximum doses at harmful levels and without proper labeling to explain the risks to consumers.

SYMPTOMS OF LIVER DAMAGE

One of the most dangerous aspects of liver failure is that sometimes its victims don’t have symptoms. For those who do experience symptoms, they most often begin with nausea and vomiting in the first 24 hours. In the next 12 to 24 hours (the latent phase), the patient may have a feeling of wellness. It’s after this time, approximately 48 and sometimes as much as 72 hours after the overdose, liver blood test begin to appear abnormal. Tests at this time should provide an accurate outlook on whether the patient will be able to undergo treatment or will need a liver transplant. Patients who don’t receive these tests could not be aware that they have experienced liver damage. Untreated liver damage can result in death, often within a few days of Acetaminophen overdose.

If you or someone you care about has been injured by a product with Acetaminophen (See comprehensive list below), contact the lawyers at Oshman & Mirisola for a free and confidential case evaluation. We will find answers, hold negligent companies responsible, and fight to get you the compensation you deserve.