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Knee replacement surgery, also known as total knee arthroplasty (TKA), is a common orthopedic surgeries. During the procedure, a surgeon replaces a damaged or diseased knee joint with artificial parts. The Arthrex iBalance is one of several different types of knee replacement systems on the market.
The Arthrex iBalance TKA contains multiple components. One of these components is a tibial tray (also called a baseplate). The tibial tray replaces the top of the tibia, or shinbone. It is made of metal and attaches to the bone with cement. (2)
The recalled iBalance tibial tray was manufactured with a smooth outer surface that was different from what was previously approved, which had a textured outer surface. This change in surface texture appears to correspond to a pattern of failed devices due to loosened tibial trays. (3)
Multiple reports from the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database describe patients requiring revision surgery due to tibial loosening. (4) (5) (6) These reports and several others suggest poor bonding between the metal implant and knee.
In December of 2015 and March of 2016, Arthrex initiated recalls of the Arthrex iBalance TKA Tibial Tray. The reason for the recalls was the “smooth texture to the outer surface of the metal” that differed from the previously approved “textured outer surface.” (7)
On February 5, 2016, Arthrex sent “Urgent Medical Device Voluntary Recall Letters” to distributors, surgeons, and medical centers instructing them to discontinue using and return the devices that had not yet been implanted. Nearly 2,400 devices had been distributed in the U.S. by the time of the recalls. (8)
In March of 2016, the FDA classified the recalls as Class II. They determined the cause of the recalls to be “Nonconforming material/component.” (9)
A knee implant is supposed to last for many years. But a loose tibial baseplate can cause an implant to fail soon after implantation. A failed implant can be excruciatingly painful and even debilitating.
A failed implant is a serious matter. If you have had a knee implant and are experiencing these symptoms, we encourage you to see your doctor for an examination.
The MAUDE database contains multiple reports of patients with Arthrex iBalance TKA implants who had to undergo revision surgery due to tibial tray loosening. (10) (11) (12)
Even more concerning is that “the success rate for revision surgery is usually lower than that for the original surgery because the bone is weaker.” (13)
If a defective product put you in unnecessary risk or damaged your health, the manufacturer should be held accountable. Arthrex iBalance patients forced to undergo revision surgery due to tibial tray loosening may be eligible to file a lawsuit.
Weitz & Luxenberg is currently accepting cases from patients who were implanted with an Arthrex iBalance TKA prior to the recall in December 2015 and subsequently had a revision, or have been told they require a revision, due to tibial baseplate loosening. We believe that if an implant design necessitates you have a revision surgery after just a couple of years, you were put at unnecessary risk and the manufacturer should be held responsible.
W&L’s attorneys in our Drug and Medical Devices Litigation Unit have years of experience and specialized training in handling complex medical device lawsuits. Under the helm of the unit’s chair, Ellen Relkin, our attorneys have a long track record of successfully representing osteoarthritis and joint patients, among many others, harmed by medical devices and pharmaceuticals:
We are also currently helping patients experiencing similar issues of component loosening in other knee implants, including the tibial baseplate of the DePuy Synthes Attune Knee and the femoral component of the Smith & Nephew Journey BCS Knee replacement system.
The attorneys at our law firm believe that when medical device companies bring defective products to market, they are gambling with the health and safety of patients. These companies should take responsibility for the harm they caused.
If you were hurt by a medical device that didn’t function properly, you should be fully compensated for the pain, suffering, medical costs, and other personal and financial injuries you suffered.