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Articles Posted in Knee Replacement Recall

Knee replacements are one of the most commonly-performed surgeries in the United States today. When the pain caused by arthritis, injuries, and years of wear and tear can’t be remedied by less invasive procedures, knee replacement implants are another option. The damaged knee joint is replaced with an implant made of plastic, metal, or a combination of the two.

Manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics, the Attune Knee System was approved by the FDA in 2010. Marketed as having the ability to provide patients with a greater range of motion and better stability, Attune implants quickly rose in popularity. Unfortunately, the reality has been less desirable. Since its approval, multiple patients have reported complications, including the need for painful revision and reconstructive surgeries due to the loosening of tibial components within the device. A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by a faulty or dangerous medical device.

But J&J and DePuy are no strangers to medical implant failures, massive recalls, or the lawsuits that inevitably follow. DePuy has fought many a legal battle over its metal-on-metal hip implants. The ASR hip implant, which was recalled in 2010, has lead to nearly 9,000 lawsuits from patients who say the failure of their implant caused serious medical complications, such as bone deterioration and blood poisoning, as well as extreme pain. DePuy also recalled its Limb Preservation System knee implant in 2013, following reports of premature failure.

The Journal of Knee Surgery published a study in 2017, in which many of the Attune Knee implants had come loose due to the cement-to-implant interface. According to researchers, the glue does not properly adhere to the smooth surface of the implant. Attune’s “roughness factor” is 60, whereas other devices may have a roughness factor of more than 200. Further, the weakness of the polyethylene plastic used in the Attune implant causes significant load-bearing stress on the other components of the device.

 

How Do I Know if My Knee Implant is Failing?

In most cases, the first sign that something is wrong will be discomfort or pain. If, however, you experience any of the following symptoms, seek medical attention.

  • Swelling, inflammation or redness around the joint
  • Infection
  • Warmth around the joint
  • Stiffness
  • Instability
  • Mobility problems
  • Clicking, popping or grinding noises when walking
  • Nerve damage

The complications above can be the result of the loosening or breaking of various device components, dislocation of the device, misalignment of the device, or damage to the surrounding bone. A MA defective medical products lawyer can help you recover damages if you’ve been injured by a faulty or dangerous medical device.

Successful knee replacement implants are supposed to last for up to 20 years. When premature failure occurs within the first few months or years, revision surgery may be necessary much sooner than the patient anticipated. Unfortunately, revision surgery is typically more painful than the initial surgery because it involves removing the device, which is cemented into the bone. In fact, poorly-implanted knee replacements can cause such severe damage to the bone that the knee must be rebuilt before a new replacement can be implanted. Patients undergoing painful revision surgeries also run the risk of exposure to infection and surgical complications, including deep vein thrombosis, nerve damage, and excessive bleeding. Continue reading

When implanted medical devices cause injuries to a patient, are improperly labeled or defectively manufactured, or otherwise fail after being implanted, a device manufacturer or the Federal Drug Administration will initiate a recall. Too often though, these recalls come after there have been hundreds of complaints filed by injured patients.

medical-doctor-1314902-m.jpgMost recently, Stryker, a leading medical device manufacturing company that specializes in developing orthopedic, neurotechnology and spine products, has issued a voluntary recall of one of its knee replacement products ShapeMatch Cutting Guides.

What Are ShapeMatch Cutting Guides?

ShapeMatch Cutting Guides are single-use, disposable cutting guides that are intended to be used as surgical instrumentation to assist surgeons in positioning the Stryker Triathlon Knee System. This software is used to guide where surgeons will cut and shape a patient’s bone before implanting the replacement knee device.

About the Recall

In April of 2013, Stryker Orthopedics issued a Level 1 voluntary recall of the Shape Match Cutting Guides, after becoming aware of the potential issues with the software. It was found that the software did not meet surgeon’s pre-operative planning parameters, and some manual edits used in the software did not meet the standards of the FDA. The overall effects these discrepancies in the software resulted in improper cutting of bones, as well as many serious adverse health consequences for patients who had Stryker system knee replacements including poorly-fitting, loose knee implants, knee fractures, chronic pain, and the need for revision surgery.

Your Consumer Rights

Like all knee replacement device manufacturers, Stryker has a legal obligation to properly design, test, and ensure their products are working correctly. They also are responsible for warning the public of any problems with their products, no matter how minor.
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