Three knee replacement systems made by DePuy, Arthrex, and Exactech have all been recalled to avoid causing knee replacement complications. Some of these complications have all required knee revision surgery to correct the problems.
A total knee replacement surgery is also called an arthroplasty. A TKR is a surgery that is performed to resurface a knee that has been previously damaged due to arthritis, or other knee injuries. The surgery is comprised of using plastic and metal parts to attach to the knee joint and the kneecap. Both use knee implants.
According to reports, some of the serious adverse effects stemming from these replacement systems include but are not limited to the following: pain, mobility issues, swelling, instability problems, fractures, disassociation of implant, inflammation, loosening of implant, change in component position, Patello-Femoral Tracking-Lateral Release, and others.
Roughly 4.4 million Americans are known to have had knee replacement surgery thus far, but reports have indicated that since that number continues to climb, more alleged complaints are associating adverse side effects and complications to failing knee implants.
Serious adverse effects and complications resulting from a defect in the knee replacement system’s design or the construction of the implant itself has further instigated recalls by the knee implant manufacturers.
The three companies that have issued recalls of their knee implant systems include: DePuy (Attune), Arthrex, and Exactech.
Arthrex iBalance Facts
One specific implant maker is Arthrex, which issued a recall of its iBalance TKA Tibial Tray in December 2015. It issued the recall after discovering that the device had a smooth texture to the outer portion or surface of the metal that was allegedly different from the manufacturer’s earlier model that had a textured outer surface.
The Arthrex iBalance is a total knee arthroplasty system that is designed to treat conditions such as osteoarthritis or post traumatic arthrosis in the knee, otherwise known as multicompartmental knee degeneration. The Arthrex iBalance was approved by the U.S. Food and Drug Administration (FDA) in December 2013 and was marketed by the manufacturer as being “a novel and innovative instrument platform that facilitates an accurate, efficient, and reproducible surgical technique.”
The Arthrex iBalance, however, was approved by the federal agency through a 510(k) process, which fast-tracks products onto the market if they are like existing products already sold.
When the recall was announced for the Arthrex iBalance, the corporation sent an Urgent Medical Device Voluntary Recall notice to physicians, surgeons, medical facilities, and distributors informing them of the recall.
DePuy Synthes Attune Knee System
The DePuy Synthes Attune Knee System was developed to reduce the recovery time of patients who undergo knee replacement surgery. Reports maintain, however, that patients have reported adverse knee replacement side effects, including pain and premature knee implant failure, that they were feeling, which instigated a later revision surgery to mediate.
Exactech Knee Implant Failures
Yet another recall, this one pertaining to the Exactech system, had maintained that the U.S. Food and Drug Administration was also showing patient complaints of premature device failure as well. The report claims that these failures are being caused by a tibial insert wear and tear of the implant.
If you or someone you love has been impacted by an Arthrex iBalance knee system or another faulty knee implant, you may be able to pursue compensation from the manufacturer. A medical device lawyer can help decide if a legal claim is right for you.
Get a Free Knee Replacement Case Review
If you or a loved one suffered from complications caused by an Attune knee implant, an Arthrex knee implant, or an Exactech knee implant, you may have a legal claim. In general, knee replacement surgery lawsuits are filed individually by each plaintiff and are not class actions. Get help now by filling out the form on this page for a FREE case evaluation.
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