Attune Knee Replacement Problems are Affecting Younger People – and the Economic Consequences can be Devastating
Knee replacement is among the most common surgeries carried out today. When done correctly, total knee arthroplasty (TKA) results in positive outcomes for 90 percent of patients who undergo the procedure, enabling those who have suffered from severe knee pain to return to their daily activities.
In 2013, the Journal of Bone and Joint Surgery published a study showing that the net benefit for a younger individual who undergoes successful TKA translates into an average dollar figure of $19,000. Multiply that by the number of TKAs that are performed annually, and the economic savings to society figures in the billions of dollars. According to that study, 85 percent of the savings came from patients who were able to return to their jobs as a result of the surgery; the remaining 15 percent came from reduced absenteeism and lower disability payments.
However, when that knee surgery goes wrong and the prosthesis fails prematurely, the cost to the individual and society can be high – particularly for a younger person during their prime earning years. A number of reports indicate that a growing number of patients under the age of 65 are undergoing TKA. According to the Arthritis Foundation, the number of TKAs performed on patients between the ages of 45 and 64 increased by 188 percent in 2014 alone. When the artificial knee fails prematurely, these patients must undergo painful and complicated revision surgery to replace the entire device, which is rarely as successful as the initial procedure. Furthermore, recovery time can be as much as 50 percent longer – in some cases, up to three months.
Unfortunately, few employers are able – or willing – to give a worker that much time off.
This is the situation faced by younger TKA patients who received the DePuy Synthes Attune knee replacement. A recent study published in the Journal of Knee Surgery noted a failure rate of over 13% for this device – and that was just based on reports filed with the FDA's Manufacturer and User Facility Device Experience database (MAUDE). The article reported 21 such failures over a two-month period alone. It is likely that the actual rate of failure is much higher when the number of cases that are not reported is factored in.
In a recent interview on The Ring of Fire, Levin Papantonio litigation attorney Daniel Nigh noted that for patients who have undergone TKA over the past six to seven years, the chance they received an Attune Knee replacement is as much as 30%. He says, “You would expect your knee implant to last you 15, 20 years...but a lot of these clients that I represent aren’t getting anywhere near this amount of time. We’re commonly seeing that on the early side, they’ll fail in one-and-a-half to two years.”
The Attune Knee System is only one of three such devices that has been failing prematurely. All three of these knee replacements have a problem in which the cement used to attach a component of the device is failing to hold a bond. All three were granted FDA approval through a regulatory shortcut known as 510(k) Premarket Notification. Nigh points out that 95 percent of new medical devices are approved this way. Instead of data based on clinical trials, he says, “You show enough to say that this product is substantially similar to another product on the market, and you get your rubber stamp.”
As a result, not only are people suffering needlessly. Productivity goes down and money and resources are drained away to correct problems that should never have occurred in the first place. In the end, we all wind up paying for DePuy's mistakes, whether we have one of their knee replacements or not.