In June, details emerged that DePuy’s Attune knee implant system, one of the most popular on the market, was experiencing higher-than-expected failure rates among patients.
The news came not from the company itself, but from a panel of independent orthopedic surgeons who deal with the Attune implant first hand. Questions arose as to how long DePuy Synthes has known about early failures of its knee products, and why they didn’t alert patients and doctors.
Now, as 2017 comes to a close, the first lawsuit has been filed against DePuy and parent company Johnson & Johnson, and the company faces thousands of lawsuits in the near future.
A Market Leader in Knee Implants
Knee replacement surgeries are an ever-growing segment of orthopedics, with nearly 750,000 procedures performed each year just in the United States.
What used to be a procedure reserved for those over retirement age is now considered an option for anyone with knee joint degeneration or limited range of motion.
In order to tap into this growing market, companies like JePuy/J&J have targeted their knee implants to a younger, more active customer. Introduced in 2013, the Attune was touted as the “largest ever research and development project from DePuy Synthes,” designed to improve movement, stability and recovery times.
Since that time, it is estimated that between 60,000 and 100,000 patients have received an Attune knee.
Doctors Identify Attune De-Bonding Risks
Although J&J continues to market their top-selling knee implant to future patients, reports show the product has experienced problems for some time.
Records show that, since 2013, officials from DePuy Synthes have filed numerous reports with the Food and Drug Administration detailing early failure of their Attune knee system. Most of these cases resulted in patients losing stability and eventually needing to have their implants replaced.
In June, a group of 9 prominent orthopedic surgeons also published a report in the Journal of Knee Surgery detailing problems they’ve encountered with the Attune device. Specifically, a higher-than-normal amount of the implants have become de-bonded (unglued) from patients’ lower legs.
In just a few months, these doctors had treated 21 patients with similar Attune knee implant de-bonding.
Side Effects of Knee implant De-bonding
Patients who received an Attune knee implant may experience certain symptoms of de-bonding, including:
These may be signs that their knee implant has become unattached from the lower leg bones, or that it never secured to the bone in the first place. Either way, this can cause chronic pain, reduced range of motion or instability when they try to stand or walk.
In order to correct these problems, many Attune patients will have to undergo another surgery to replace or repair their device much sooner than they expected.
Lawsuit Alleges J&J/DePuy Failed to Warn of Attune Risks
In September, an Alabama patient filed what is believed to be the first lawsuit against Johnson & Johnson and DePuy Orthopedics for the Attune knee implant, alleging that the device failed much earlier than intended and the company failed to warn of the dangers.
Since that time, lawyers have investigated hundreds of potential cases. And, with the popularity of these devices, experts believe that thousands of affected patients will eventually come forward.
J&J could be liable for significant damages to those affected. The cost of revision surgery alone can range from $50,000 to $100,000, plus lost time and pain and suffering.
In 2013, DePuy agreed to pay $2.5 billion to settle thousands of cases from patients stemming from its defective hip implant devices, at an average of around $250,000 per case.
Lawyers are continuing to investigate and file cases for those who have experienced complications with their DePuy knee implant. To speak directly with a lawyer at no cost, or to get more information on the problems surrounding Attune knees, contact DrugNews today.
Sources:
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
Orthopedic Design & Technology. First U.S. Lawsuit Filed Against DePuy-Synthes for Attune Knee Replacement Failure. (September 18, 2017). Retrieved from https://www.odtmag.com/contents/view_breaking-news/2017-09-18/first-us-lawsuit-filed-against-depuy-synthes-for-attune-knee-replacement-failure/
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