Arthrex iBalance Total Knee Arthroplasty

Arthrex Inc. claims its iBalance Total Knee Arthroplasty System is a novel and innovative product for total knee replacement. Its studies show improvement in pain, function and quality of life in people who use the device. But in 2015, Arthrex announced a recall of the iBalance TKA Tibial Trays, and now the company faces lawsuits.

Arthrex iBalance Total Knee Arthroplasty
Arthrex iBalance Facts
  1. Uses Total knee replacement
  2. Complications Loosening, pain, instability, swelling, infection, device failure
  3. Manufacturer Arthrex Inc.

The Arthrex iBalance Total Knee Arthroplasty (TKA) System is a knee implant and instrument kit that allows surgeons to perform total knee replacements in patients who’ve lost cartilage in their knees because of osteoarthritis. The iBalance TKA also helps treat post-traumatic arthritis, a condition that occurs when a joint wears out because of injuries from sports, vehicle accidents, falls or other trauma.

Florida-based medical device manufacturer Arthrex Inc. markets the iBalance TKA. In 2017, the company made $2 billion in annual revenue, according to Forbes. Its headquarters is in Naples.

According to Arthrex, the iBalance TKA matches the curvature of the normal knee, which allows for maximum flexion.

“Highly anatomic femoral and tibial resurfacing implants and a novel and innovative instrument platform facilitate an accurate, efficient and reproducible surgical technique,” Arthrex claims on its website.

A clinical outcomes report by Arthrex suggested a “trend toward favorable outcomes” among patients who had had surgery with an iBalance prosthesis. The report, which was revised in February 2018, specifically looked at pain, function and quality-of-life scores over four years. However, the report noted that more analysis was needed to determine whether the results were statistically significant.

Before Arthrex marketed the iBalance TKA, a company called Accelerated Innovation LLC sold it as the Accin Total Knee System. The U.S. Food and Drug Administration originally cleared the device for sale in 2008.

In 2015, Arthrex recalled more than 2,300 iBalance TKA Tibial Trays. People who claim their devices failed and caused them injuries, including the need for revision surgery to remove and replace the implant, have filed knee replacement lawsuits against the company.

Knee Replacement Surgery with Arthrex iBalance TKA System

The Arthrex iBalance TKA System provides the surgeon with several tools to assist in knee replacement surgery and a pamphlet with detailed instructions. The iBalance implant is made of metal and polyethylene plastic parts.

After placing the patient under general anesthesia, the surgeon will cut part of the femoral (upper thigh) bone at the joint to make a flat surface. Next, the doctor will cut the tibia (lower part of the knee bone) at the joint.

Fact
Family members should be aware that after they leave the patient to go into the operating room, it may take a few hours before the surgeon can discuss the results of surgery.
Source: Arthrex: A Patient’s Guide to Total Knee Replacement

After measuring and choosing the right size implant parts, the doctor will secure the iBalance TKA Tibial Tray component and then the femoral component with a layer of bone cement. The surgeon will also remove the patella (kneecap) and reattach it with a patellar component and bone cement.

Components of knee replacement surgery joint
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After the bone cement has hardened, the surgeon will check the patient’s range of motion, joint tension and balance. Finally, a polyethylene plastic tibial insert goes in between the tibial and femoral metal pieces. This provides a smooth surface and cushion for the knee to flex.

Most patients spend 1 to 2 hours in the recovery room after surgery. Recovery may take several weeks. Arthrex recommends not driving for two to three weeks after surgery and attending outpatient physical therapy two to three times a week. Patients may also do therapy exercises at home.

iBalance TKA Tibial Tray Recall

On Dec. 17, 2015, Arthrex announced a voluntary recall of 2,378 units of its iBalance TKA Tibial Tray. The tibial tray is a metal piece that attaches to the shinbone and provides support for the upper part of the implant.

Arthrex said the reason for the recall was that the devices were “reported to have a smooth texture to the outer surface of the metal, which differed from a [sic] previous that had a textured outer surface.”

Arthrex iBalance TKA Tibial Tray Sizes and Catalog Numbers Included in the Recall
  • Size 2 - Catalog # AR-503-TTTC
  • Size 3 - Catalog # AR-503-TTTD
  • Size 4 -Catalog # AR-503-TTTE
  • Size 5 - Catalog # AR-503-TTTF
  • Size 6 - Catalog # AR-503-TTTG
  • Size 7 -Catalog # AR-503-TTTH
  • Size 8 - Catalog # AR-503-TTTJ

On Feb. 5, 2016, Arthrex sent Urgent Medical Device Voluntary Recall letters to doctors and distributors. The company instructed doctors and distributors to stop using the devices and return any that had not been implanted.

The recall ended on Dec. 14, 2016.

Tibial Tray Loosening and Other iBalance TKA Problems

In addition to typical problems that can occur after any surgery, such as infection, blood clots and surgery site pain, some patients have reported problems specific to iBalance TKA products, especially the tibial tray that was recalled in 2015.

The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database received several reports of device failures requiring revision surgery because of tibial plate loosening. In some cases, patients had both knees replaced.

Problems reported to MAUDE with iBalance knee implants include:
  • Loosening
  • Pain
  • Dislocation
  • Component migration
  • Instability
  • Stiffness
  • Swelling
  • Device failure
  • Infection

Some knee implant complications that may indicate device failure include pain, swelling, or difficulty moving the knee and walking.

One patient who had the iBalance TKA implanted in both knees in 2013 reported that two years after surgery, he started to have swelling and pain in his left knee. His doctor drained fluid from his knee three times, once every six months. Still, he suffered pain.

He reported that his knee would slip out of place and that the instability was so bad that sometimes he would fall. When he walked, both knees would shift. His doctor told him the cement was loosening and he would require revision surgery.  He had revision surgery in 2018.

Did you require revision surgery after your Arthrex iBalance knee implant failed? Get a Free Case Review

Lawsuits Say iBalance Knee Components Loosened

After the recall in 2015, several patients filed lawsuits against Arthrex. They claim the iBalance knee implant is defective in design and manufacture. Furthermore, lawsuits accuse Arthrex of being negligent and failing to warn surgeons and patients of the risks.

“[T]hey knew or should have known that their knee implant was unreasonably dangerous,” according to a complaint filed on behalf of Mandy and Gary VanBibber.

Lawyers are accepting cases on behalf of people who have suffered injuries from an iBalance knee that was implanted before the Dec. 17, 2015 recall. If a person had revision surgery or their doctor told them they would need surgery because of tibial plate loosening, they may qualify for compensation.

Mandy VanBibber

Ohio resident Many Vanbibber had her iBalance knees implanted on Dec. 8, 2014. She had surgery with Arthrex components on both knees. Shortly after, she suffered pain, swelling and instability in her right knee. She also walked with an abnormal gait.

An X-ray showed component loosening had caused her pain and difficulty extending her knee. On July 12, 2016, she had revision surgery. Her surgeon said the component was so loose, “it came out by simply pulling on it.”

VanBibber filed her lawsuit in 2017.

Angela Owen

On Nov. 6, 2015, Angela Owen had a total left knee replacement with an iBalance knee system. After, she suffered severe pain, swelling and numbness in her left knee.

Less than a year later, on April 18, 2016, she had revision surgery. During the surgery, the surgeon noted the tibial tray was extremely loose. The component was listed on Arthrex’s recall list. Owen filed her lawsuit in 2019.

“The Arthrex iBalance implanted in Angela Owen failed due to loosening of the tibial tray. The tibial tray was defective in its manufacture in that the under surface of the tibial tray lacked the proper roughness and texture necessary to aid in adhesion to the bone,” Owen’s lawsuit said.

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

12 Cited Research Articles

  1. Arthrex. (n.d.). A Patient’s Guide to Total Knee Replacement. Retrieved from https://www.arthrex.com/link/asset/oejCR7aAY0GiwwFTN9Yjow
  2. Arthrex. (n.d.). iBalance Primary TKA Outcomes. Retrieved from https://www.arthrex.com/link/asset/JAvmvdq6aEG0OwFWjuudjQ
  3. Arthrex. (n.d.). iBalance TKA Surgical Technique. Retrieved from https://www.arthrex.com/knee/ibalance-tka-surgical-technique
  4. Arthrex. (n.d.). iBalance TKA. Retrieved from https://www.arthrex.com/knee/ibalance-tka
  5. Arthrex. (n.d.). Total Knee Replacement. Retrieved from https://www.arthrex.com/knee/total-knee-replacement
  6. Forbes. (2018, October 24). #297 Arthrex. Retrieved from https://www.forbes.com/companies/arthrex/#2d42609571f4
  7. Owen v. Arthrex, Inc. (2019, February 25). United States District Court For The Western District of Hot Springs Division, Complaint for Damages and Jury Demand. Case No. 6:19-cv-006026. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2019-02-25-Complaint.pdf
  8. U.S. Food and Drug Administration. (2008, October 17). 510(k) Premarket Notification, Accin Total Knee System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K081127
  9. U.S. Food and Drug Administration. (2015, December 17). Class 2 Device Recall Arthrex IBalance TKA Tibial Tray. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143925
  10. U.S. Food and Drug Administration. (2018, June 8). MAUDE Adverse Event Report: Arthrex INC. iBalance TKA Bearing, PS Size 7, 10mm Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7703843&pc=JWH
  11. U.S. Food and Drug Administration. (n.d.). MAUDE - Manufacturer and User Facility Device Experience. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
  12. VanBibber v. Arthrex et al. (2017, October 3). In The United States District Court For The Southern District of Ohio Eastern Division, Complaint Jury Demand Endorsed Hereon. Case No. 2:17-cv-869. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2017-10-03-Arthrex-Complaint.pdf
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