Knee replacement and knee implant lawsuits allege that devices loosened or did not last as long as they should. Zimmer faced over 15,000 Biomet lawsuits over its NexGen implant. DePuy Synthes Attune Knee implant lawsuits were also a big thing. Now Exactech recall lawsuits will be getting filed in massive numbers in 2022 after a big recall.
There have been a lot of questions about hip and knee replacements in recent years. DePuy, Exactech, Stryker, and Zimmer have had – to put it mildly – concerns raised about their products. These companies would argue that the problems are mostly with patients who are having bad outcomes and blaming the insurance companies.
Exactech Is Making Big Money
Plaintiffs’ attorneys filing these lawsuits paint a different picture, one that involves a theme every jury will understand: greed. The hip and knee implant products market is enormous, extremely lucrative, and tightly concentrated. Global sales of knee and hip orthopedic devices exceed $12.5 billion by 2027.
Think about that. You keep hearing over and over during the ongoing labor dispute about how the NFL is “big business.” The market for hip and knee replacement and implants are even bigger and I’d be willing to bet you a lot of money the profit margins are much higher (at least until the lawsuits are over and settlement amounts are paid).
Of course, this information is coming to you from a plaintiffs’ lawyer (a phrase I have admittedly repeated in this post). If you take that with a grain of salt, let’s look at what the federal government has said. The Justice Department and Department of Health and Human Services settled criminal and civil claims against four of the five largest hip/knee replacement companies in the country. The fine? $311 million.
What’s the point? In the race to get their fair share of the hip/knee implant market, these companies rushed products onto the market and kept their products on the market for way too long.
The Exactech Opterak Knee Implant
The Exactech Optetrak knee implant acts as a replacement for the proximal tibia during knee arthroplasty, during either a revision or a primary procedure. Its purpose is to provide stability at the back of the knee and must be cemented into place. In most cases, the device is used to compensate for damage to the posterior cruciate ligament or PCL.
What Is a Total Knee Arthoplast (TKA)?
A total knee arthroplasty (TKA) or total knee replacement, is a commonly performed orthopedic procedure. In a TKA, the surgeon makes an incision in the front of the leg over the knee. The surgeon cleans out the femur portion of the knee to remove diseased bone. The surgeon performing the TKA will then drill a hole in the femur to support the femoral component of the implant. The surgeon then
places a femoral implant onto the distal femur using surgical cement.
From there, the surgeon will remove diseased bone from the tibia and line it with the tibial tray. A hole is drilled to implant the tibial tray. The tibial tray is then implanted using surgical cement. A polyethylene tibial insert is then implanted between the femoral implant and the tibial tray
On February 7, 2022, Ecactech send out a Dear Doctor letter for users of knee and ankle arthroplasty polyethylene inserts to provide recommendations for surgeons after the August 31, 2022 Exatech recall.
Why Is There an Exactech Knee Implant Recall?
Exactech says that testing has demonstrated that its inserts manufactured since 2004 were packaged in out-of-specification vacuum bags that were oxygen resistant but did not have a secondary barrier layer. That secondary barrier should have contacted ethylene-vinyl alcohol that would protect against oxygen exposure.
What Is the Risk of the Exactech Recall?
The failure to protect the Exactach implant from oxygen exposure is the reason for the Exactech recall. What is the problem with oxygen? Oxidation will degrade the knee insert over time. This can cause a host of maladies, including bone loss, component fracture, and other complications that will require corrective revision surgery.
That will be the primary injury in any Exactech knee lawsuit. The need for corrective revision knee surgery.
Who is Exactech?
Exactech is a Gainsville-based developer and producer of bone and joint restoration products for extremities, knees, and hips. Our lawyers have not talked about the Exactech hip implant lawsuits. But there will be a number of claims in those cases as well. The company has been gaining market share and raising its profile in recent years.
FDA Procedure for Approving the Exactech Optetrak
Exactech obtained 510(k) clearance for various Optetrak devices and tibial inserts including the Opterak Logic, Optetrak PS, Optetrak Offset Tibial Tray, Optetrak Hi-Flex PS, Optetrak Finned Tibial Tray, Optetrak RBK Tibial Insert, Optetrak RBK Tibial Tray, and Optetrak CR Slope.
One of the key allegations in an Exactech lawsuit will be that Exactech improperly utilized the 510(k) FDA fast-track FDA approval, to circumvent the need for full FDA review. The company marketed this too, pushing three decades of clinical success.
Hiring a Knee Implant Lawyer
If you need a lawyer for your knee implant lawsuit against Exactech of any other manufacturer, call us today at 800-553-8082 or get a free consultation online.