Arthrex iBalance TKA Lawsuit
(Total Knee Replacement)
Problem summary
The knee is the largest joint in the human body, responsible for supporting most of the body’s weight, and as a result, the knee joint is extremely vulnerable to injury or trauma possibly resulting in the development of osteoarthritis later in life. Used as a treatment for multi-compartmental knee cartilage degeneration resulting from osteoarthritis or post-traumatic arthrosis, the Arthrex iBalance TKA system is a prosthetic knee implant marketed by Arthrex as a more effective and longer-lasting alternative to traditional total knee replacement. However, while successful knee replacement procedures can help relieve pain and return mobility to patients with knee injuries or severe arthritis, many of the knee implants currently on the market have been linked to serious complications resulting in persistent pain and implant failure requiring revision surgery. With regard to the Arthrex iBalance knee implant, adverse event reports have shown that problems with tibial loosening, possibly as a result of poor bonding between the implant and the patient’s knee bones, may cause premature device failure.
About Arthrex iBalance TKA Knees
Total knee replacement (TKR), or total knee arthroplasty (TKA), is a surgical procedure designed to resurface a knee joint damaged by severe arthritis or knee injuries, which is done by capping the ends of the bones with metal or plastic components. Traditional total knee replacement procedures typically require additional surgeries in the future to remove metal plates and screws, but the Arthrex iBalance total knee implant was designed as an alternative option for multi-compartmental knee cartilage degeneration, one that doesn’t require the insertion of metal plates or screws. Still, adverse event reports indicate that recipients of the Arthrex iBalance knee system may be forced to undergo revision surgery anyway, to either remove or replace devices that loosen or fail prematurely.
The Arthrex iBalance knee was approved by the FDA in December 2013, via the agency’s controversial 510(k) premarket approval program, which allows device manufacturers to fast-track their products that are “substantially equivalent” to devices already on the market. Unfortunately, this means that new knee implants can enter the market without being subjected to rigorous testing, so long as they are similar to previously approved prosthetic knee devices, many of which later end up being recalled. Despite a growing number of adverse event reports submitted to the FDA detailing painful complications and instances of premature device failure, some of which occur within just two years of the initial replacement surgery, knee implant manufacturers like Arthrex continue to market their devices as safe and effective.
Artificial knee implants of all types have been plagued by reports of implant loosening and device dislocation resulting in significant pain, inflammation, loss of mobility and the need for revision surgery, and many of these prosthetic knees have been recalled from the market as a result of faulty designs. In 2016, the FDA announced a recall of more than 2,300 Arthrex iBalance TKA Tibial Tray components due to manufacturing irregularities that resulted in some components having a smooth outer surface to the metal, rather than a textured outer surface. As a result of these irregularities, Arthrex found that the iBalance device components were not compatible with older textured knee replacement models and were therefore not suitable for patient use.
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Arthrex iBalance Knee Implant Complications
- Persistent joint pain
- Infection
- Swelling around the knee joint
- Kneecap shifting out of place
- Inflammation
- Bone damage
- Knee joint instability
- Decrease in range of motion
- Problems with mobility
- Failure of components to bond properly
- Implant loosening
- Implant dislocation
- Need for revision surgery
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Arthrex iBalance TKA Resources and Studies
Arthrex iBalance TKA
Settlements & Litigation
Approximately 4.4 million Americans have had their knees replaced with prosthetic devices, and as the number of knee replacement surgeries increases, so, too, does the number of adverse event reports submitted to the FDA in connection with faulty knee implants. For instance, patients implanted with the Arthrex iBalance TKA system may require revision surgery if their implant fails or loosens as a result of improper bonding between the metal implant and the patient’s knee bones. Allegations raised in Arthrex iBalance knee implant lawsuits include claims that design defects may cause the implants to loosen or otherwise fail prematurely, resulting in the need for revision surgery. Not only can revision surgery be extremely painful, it poses its own risk of complications and typically has a lower success rate than initial replacement procedures.
If you or a loved one has suffered due to Arthrex iBalance total knee replacement loosening or failure, you may be able to file a product liability lawsuit for damages. Contact an experienced defective knee implant attorney today to discuss your possible compensation options.
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