The rate of knee replacement surgeries each year in the United States has tripled in recent decades to almost 750,000 annually, and the number is expected to continue growing to roughly 3.5 million procedures over the next decade.
Without defects, infection or an accident, knee implants can last up to 20 years and have failure rates of less than 2%. However, doctors recently uncovered a trend of early failure in one of the most popular knee implant models: the DePuy Synthes Attune.
Ironically, the news comes just after DePuy parent company Johnson & Johnson lauded the results of a British study suggesting Attune knees were less likely to fail than the industry average. Now, doctors and thousands of patients are questioning whether the Attune is truly a safe implant and if DePuy sold it knowing the risks.
J&J Claims Attune Among the Safest
Last May, DePuy Synthes celebrated the results of a four-year study of more than 10,000 patients who had received Attune knee implants in the United Kingdom based on data from the National Joint Registry.
The findings, introduced at the annual European Federation National Associations of Orthopedics & Traumatology Congress in Vienna, showed the number of patients needing revision surgeries within 4 years of implant were only 1.3%, compared to an average of 1.9% for all knee implants.
That suggested the Attune implants may be 31% less likely to experience early failure.
Orthopedic Surgeons Report Attune Knee Failures
Within a week of the U.K study release, a group of doctors published a report in the Journal of Knee Surgery telling a drastically different story: Attune patients were experiencing a rash of failures due to implant de-bonding.
The report came on June 7th, when a group of 9 prominent joint surgeons from New York to Washington State published their findings.
According to the paper, doctors began reporting problems with de-bonding, or devices becoming unglued from tibial bone attachments, as early as 2013 when the Attune was first introduced.
Overall, the group of physicians said they had noticed a higher rate of implant de-bonding among Attune knee patients than normal. In some cases, the implant was found to have never connected to the lower leg bones at all.
Based on the conflicting reports, it is difficult to determine if the Attune knee implant is safer or more likely to fail than similar devices. However, it is clear that J&J has known of the problems since 2013 without adding warnings for consumers.
Side Effects of Attune Knee De-bonding
Those patients who experience de-bonding of their Attune knee implants may suffer severe side effects, such as:
These could be signals of an unattached knee implant, which can make standing or walking very difficult. Since an estimated 70,000 or more patients have received an Attune knee, experts are concerned that thousands may experience de-bonding.
Unfortunately, the only way to correct these defects is with invasive surgery to replace the device.
Lawsuits Filed For Attune Knee Failures
Last year, lawyers began new litigation against J&J/DePuy Synthes for those patients who suffered Attune knee failure, based on the company’s failure to warn of the risks.
Anyone who received an implant since 2013 and has experienced symptoms of de-bonding should talk with their doctor. They should also speak with a lawyer that can review their medical records to determine their rights.
Those affected may be entitled to substantial compensation. Contact DrugNews today for more information or to talk directly with a lawyer.
Perriello, B. J&J’s DePuy Synthes touts 4-year Attune knee revision data. Mass Device. (May 31, 2017). Retrieved from http://www.massdevice.com/jjs-depuy-synthes-touts-4-year-attune-knee-data/
Bonutti, P. et al. Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant–Cement Interface. The Journal of Knee Surgery. (June 7, 2017). Retrieved from https://www.thieme-connect.com/DOI/DOI?10.1055/s-0037-1603756
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Since news broke last year that medical device maker DePuy Orthopedics had ordered 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.