Knee replacement patients who received implants like the Arthrex iBalance Total Knee Arthroplasty (TKA) System have reported experiencing severe health complications, many of which require the need for painful revision surgery to remove the implant.
Free Confidential Lawsuit Evaluation: If you or a loved one experienced complications or needed revision surgery following knee replacement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What is Total Knee Replacement?
Total knee replacement (TKR), also called arthroplasty, is a surgery designed to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint and kneecap. Arthroplasty is typically performed on patients with severe arthritis or knee injuries.
What is the iBalance TKA?
The iBalance Total Knee Arthroplasty (TKA) System was designed to treat multi-compartmental knee cartilage degeneration as a result of osteoarthritis or post-traumatic arthrosis in the knee. Arthrex markets the device as “a novel and innovative instrument platform that facilitates an accurate, efficient and reproducible surgical technique.” The iBalance knee implant was cleared by the U.S. Food & Drug Administration (FDA) in December 2013 via the agency’s controversial 510(k) loophole, which fastracks devices to market that are “substantially equivalent” to existing products.
What’s the Problem?
It has been estimated that more than one million people undergo knee replacement surgery each year in the U.S. While these surgeries can work wonders in returning mobility to patients, many knee replacements have a less-than-stellar post-surgery track record. Allegedly defective knee implants have been linked to adverse health consequences including nerve damage, life-threatening infections, deep vein thrombosis (DVT) and more.
Knee Implant Complications
- Severe pain
- Bone damage
- Muscle damage
- Loss of / lack of bonding of the knee implant to the bone
- Tibial loosening
- Disassociation of the insert
- Change in position of the components
- Patello-Femoral Tracking-Lateral Release
- Knee replacement failure
- The need for revision surgery
Arthrex Knee Recall
In March 2016, Arthrex announced a nationwide recall for its IBalance TKA Tibial Tray after it was found that the devices had a smooth texture to the outer surface of the metal which was different from an earlier model that had a textured outer surface. The company sent Urgent Medical Device Voluntary Recall letters to their distributors and Surgeons/Medical Facilities reporting the removal. Approximately 2,378 Arthrex iBalance tibial trays were affected by the recall, according to the FDA.
Patent Infringement Lawsuit
In 2011, medical device manufacturer Smith & Nephew Plc was awarded $85 million after a federal jury in Oregon found that Arthrex had infringed the company’s patent on surgical anchors. The jury determined that Arthrex’s Bio- SutureTak, Peek SutureTak, PushLock and Bio-PushLock violated the patent rights, according to Smith & Nephew.
Do I Have an Arthrex Knee Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Arthrex knee lawsuits. We are handling individual litigation nationwide and currently accepting new knee implant failure cases in all 50 states.
Free Case Evaluation: Again, if you had problems after knee replacement surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.