On February 1st, a Kentucky man filed the latest DePuy Attune knee lawsuit against Warsaw, Indiana-based DePuy Orthopedics, alleging that defective design of their Attune knee implants led to tibial loosening and device failure.
The suit joins a growing number of claims filed around the country against DePuy over its Attune line of knee implants. It’s alleged that a defective design in the lower tibial plate of the implant reduces bonding between the device and the tibia bone and makes it easily prone to loosening.
Lawyers expect hundreds or more cases will eventually be filed and likely will be consolidated into a class-action type multidistrict litigation court.
Signs Your Knee Implant May Have Become Unglued
Potential symptoms of a loosening knee implant can include:
Sometimes, a detached knee implant can be identified by x-ray tests. However, many surgeons have reported that they couldn’t tell a knee device had become loose until they performed a second surgery to see it directly.
Implant Loosening Leads to Revision Surgery
In the case of Robert Long, he underwent a total right knee replacement surgery in 2015 near his home in Somerset, Kentucky and received a DePuy Attune knee implant in the process.
After only a year or so, Mr. Long began suffering constant and severe pain, difficulty walking, and trouble with stability. His doctor performed x-rays which showed the lower part of his knee implant, the tibial baseplate, had become unglued from his tibia bone.
After only 2 years, Mr. Long was forced to undergo a new surgery to remove the failed Attune implant and replace it with a different model.
Both he and his doctors stated they never would have used the Attune implant if they had known it was prone to loosening. However, DePuy didn’t disclose these dangers despite having years of information they were failing.
Higher Failure Rates With Attune Knee Implants
DePuy Orthopedics boasted that the revolutionary Attune knee implant took years to conceptualize and cost approximately $200 million in product research and development. In fact, they called it their largest product development in history.
And, in the years since it was approved by the FDA in 2010, nearly 400,000 patients worldwide have been fitted with Attune knee implants.
However, one small design alteration may have spelled its demise: The bottom part of the implant system that has to be glued to the patient’s tibia bone, called the tibia baseplate, is nearly 75% smoother than previous models. Because of this, the surgical glue doesn’t have anything to bond to.
In just a few years since the Attune was first launched, the FDA has reported receiving around 1,500 notices of device failures. In almost half of the cases the patients needed a complete redo surgery.
By comparison, a similar knee implant - the Zimmer Persona, which has sold 384,000 units – has only reported 183 failures.
The Risks of a Faulty Knee Implant and Revision Surgery
In addition to having a higher chance of failure with Attune knee implants, the damage done by a faulty implant can be severe. When the device loosens, the added wear can damage surrounding bone. Infections can cause additional bone loss.
And, since doctors have to sculpt the lower leg bones to accept new implants each time, patients needing a revision surgery sooner than expected can face more damage to their natural bone than necessary.
For these reasons, doctors report that patients who need revision surgery to replace a worn out or defective knee implant have much lower chances for successful surgery. And, they face 2-3 times the amount of pain, suffering, therapy and rehab as someone with a successful first implant.
Did DePuy Try to Hide an Attune Knee Recall?
DePuy has stated publicly that they are not recalling the Attune knee implants which have resulted in hundreds of FDA reports and surgeries. However, as the lawsuit filed by Mr. Long points out, they’ve tried to replace the device without alerting consumers or doctors.
As early as December 2016, DePuy started responding to FDA reports of Attune knee implant failure by stating:
“The analysis and investigations eventually led to a new product development project, which will enhance fixation and make the product more robust to surgical technique per co (b)(4).”
In 2016, the company applied to the FDA for approval of a new product, called the Attune S+, which would have bigger features and a rougher finish on the tibial plate to help with bonding of the implant to bone cement. This was designed to lower “factors which can result in a reduction in cement to implant bond.”
The new Attune S+ was finally approved by the FDA in June 2017 and is replacing the original Attune in new surgeries. However, the company never issued a formal recall for the old device or warned doctors of its faults.
New Attune Knee Lawsuits Still Being Filed
Lawyers point out that DePuy knew of reports to the FDA of the Attune problems as early as 2014, and acknowledged knowing of the issues in their own words when they filed the application for the new Attune S+. However, they failed to warn patients of the safety issues.
Now, the company faces lawsuits from hundreds or thousands of patients alleging they received faulty implants. In most cases, victims could be entitled to compensation for past and future medical treatment, disability, pain, suffering and lost wages or enjoyment. Together, these could add up to very significant awards.
Lawyers are still filing new lawsuits in 2018 on behalf of those who suffered loosening of an Attune knee implant. And, since many cases can’t be diagnosed without an x-ray or surgery, they are urging anyone with the symptoms above to have their case investigated.
It costs nothing to speak with a lawyer, investigate your case or file a claim unless you receive an award. Contact DrugNews today for more information about defective knee implants, or to speak directly with a lawyer.
Long v. DePuy Synthes, et al. Case No. 6:18-cv-00032-GFVT. U.S. Dist. E. Kentucky. (February 1, 2018). Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2018-2-1-attune-long-complaint.pdf
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Since news broke last year that medical device maker DePuy Orthopedics may have instituted a secret DePuy Attune knee recall, the company has been trying to combat a series of negative reports and hundreds of consumer lawsuits by those needing revision surgery.