DePuy Knee Replacement Implant Lawsuits, Side Effects: Early Failure Need For Revision Surgery

DePuy Knee Replacement Implant | Recall, Lawsuits, | Side Effects: Severe Swelling, Disabling Pain, Loosening of Implant, Joint Damage, Muscle Damage, Infection, Discomfort After Knee Replacement, Loosening of Replacement Knee, A Loose Feeling In The Replacement Joint, Difficulty Walking

Have you suffered an premature failure of a DePuy Orthopaedics knee replacement device? Premature failure of a knee implant can lead to severe injuries, as well as the need for painful revision surgery and rehab. Recovery from a failed joint implant such as a DePuy knee replacement can take as long as six months.

The defective medical device lawyers at Gilman Law LLP are reviewing potential lawsuits on behalf of individuals who received a DePuy Orthopaedics knee replacement implant, and are experiencing side effects that may need additional knee surgery. If your DePuy knee implant failed after just a few years, we want to hear from you today. Our DePuy knee replacement failure lawyers are offering free legal consultations to anyone who believes they were a victim of a faulty knee implant.

DePuy Knee Replacement Implant Recalls

In 2001, the British government’s Medical Devices Agency issued a recall of knee implant Hylamer liners made by DePuy that had been sterilized with gamma radiation in air. The recall was conducted after a study showed that patients were showing a high failure rate -67.6 % within five years. That was thirteen times the expected failure rate for the device. The use of gamma radiation in air is known to increase the risk of oxidation, which can make an implant brittle and prone to breaking down. Because of this risk, manufacturers have begun using ethylene oxide, or gas plasma, to sterilize components.

In 2008, DePuy issued another recall on its LCS Knee Orthopedic Knee Implant – Meniscal bearing insert. This product is intended to replace a knee joint in order to relieve pain and restore function to the knee. The reason for the recall was that the product was not labeled properly and mis-etched as to size.

In 2009, DePuy issued an international recall of the LCS® Duofix™ Femoral Component (all lots). (This recall occurred outside the U.S., as the component has not been approved for sale by the U.S. Food & Drug Administration.) In its recall notice, the company said it identified increased revision rates associated with the LCS® Duofix™ Femoral Component, predominantly in Australia. The Australian revision rate in 2009 was 1.45% and the overall global revision rate with the LCS® Duofix™ femoral component in 2009 was 0.57%.
Symptoms of Knee Implant Failures

Knee Replacement Implant side effects and complications that may mean the knee replacement device is failing and that you should contact your doctor immediately:

• Loosening and Instability: If your knee “gives out” when you stand or put weight on it, or you experience hyper-mobility (your knee is prone to moving unnaturally – backwards or sideways), something is likely wrong. This condition is worsened when the surrounding ligaments become inflamed as well and lose their tension
• Swelling: This is generally due to inflammation of the knee lining or synovium, which, in turn, causes increased production of fluid as a response to irritation. When the body cannot absorb the amount of fluid produced the effusion or accumulation causes swelling.
• Heat or Warmth in the Knee: This is a normal sensation for several months after knee surgery, but if it persists or comes back, there is a problem.
• Pain: This may manifest as a minor soreness or it can be an acute, severe pain that presents upon motion or as a constant throbbing.
  If your doctor determines that your DePuy knee implant has failed, you will likely have to undergo revision surgery. Revision knee surgery is much more difficult than initial implantation and is often complicated by bone loss.

FDA Warns DePuy Over Illegal Marketing Of Hip Implant and Knee Replacement Products

August 19th, 2010 – DePuy Orthopaedics, Johnson & Johnson’s medical device subsidiary has run afoul of federal regulators. The company has been warned recently by the FDA that the marketing of the TruMatch Personalized Solutions System and the Corail Hip System are illegal

The FDA issued a warning letter to DePuy Orthopaedics, Inc. president David Floyd on August 19 and DePuy Orthopaedics unit has 15 days to respond to the letter either by taking corrective action or giving a reason for why corrective action cannot be taken immediately. DePuy Orthopaedics has also been ordered to halt marketing on the TruMatch Personalized Solutions System and the Corail Hip System, which the FDA considers to both be unapproved medical devices.

The TruMatch Personalized Solutions System helps doctors shape knee replacement implants to better fit their patients, has not been approved for use in the U.S., according to the letter. The FDA claims DePuy Orthopaedics never told them it intended to commercially distribute the product.

The FDA also accuses DePuy of getting the Corail hip implant approved quickly by giving inaccurate information regarding its design and use. The Corail system was approved under the FDA’s controversial 510(k) premarket approval system; an expedited process that requires that the medical device be functionally equivalent to a device already on the market in order to fast-track its approval. However, according to the warning letter, DePuy’s brochure on the device lists a number of claims about the device’s capabilities and specifications that were never approved by federal regulators.

Legal Help for Victims of the DePuy Knee Replacement Implant

The DePuy Knee Replacement Implant lawyers at Gilman Law LLP are reviewing potential injury lawsuits and class action lawsuits for patients of the DePuy Knee Replacement Implant. To have your case reviewed by one of our DePuy Knee Replacement Implant lawyers, for a free consultation and claim evaluation, please fill out the online form on the left or call Toll Free at 1-888-252-0048.