Laura Pennington  |  May 6, 2019

Category: Legal News

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Woman requiring revision total knee replacement shows her scarsIf a knee replacement fails, patients can face significant problems. An increasing number of patients have reported problems with knee replacement devices that failed much sooner than expected, requiring additional medical intervention.

Why Do Knee Replacements Fail?

Knee replacements can fail for a variety of reasons including stiffness, fractures, instability, infection, wear and loosening.

Various knee implant manufacturers have issued complete or partial recalls of their products for a variety of design defects.

In 2016, global medical device company Arthrex issued an Urgent Medical Device Voluntary Recall of nearly 2,400 of its IBalance TKA Tibial Tray after learning of problems with the texture of the outer surface of the metal, causing the implant’s components to be incompatible with earlier models with rougher textures.

What Happens When a Replacement Knee Fails?

A second surgery, a complex procedure called revision total knee replacement, may be necessary if an original knee replacement fails, according to the American Academy of Orthopaedic Surgeons (AAOS).

In revision total knee replacement, some or all of the parts of the original prosthesis are removed and replaced with new ones.

“Revision surgery is different than primary total knee replacement,” the AAOS states. “It is a longer, more complex procedure that requires extensive planning, and specialized implants and tools to achieve a good result.”

In 2012, Exactech’s Optetrak Logic Total Knee System was recalled because the device was “determined to be out of dimensional specification,” according to the U.S. Food and Drug Administration.

What Are Warning Signs of Knee Replacement Fails?

It’s important for patients to recognize the signs of early failure. Common indicators of knee replacement failure include knee instability, pain and reduced knee function, according to New York City’s Hospital for Special Surgery (HSS), the oldest orthopaedic hospital in the United States.

HSS also notes that “persistent pain and swelling can indicate loosening, wear, or infection, and the location of the pain can be all over the knee (generalized) or in one particular area (localized).”

What Are the Issues With Arthrex’s Device? 

Some have alleged that the company’s IBalance TKA tibial tray was defective from the time it came on the market.  Tibial plate bonding failures have wreaked havoc on some patients.

After suffering a range of complications from the Arthrex knee replacement system, with some patients ultimately requiring revision total knee replacement surgery, lawsuits have been filed against the company. Additional surgeries means additional risk for things like post-operative infection, bone loss and damage to tissue and nerves.

Arthrex has also been accused of withholding safety information from surgeons, regulators and consumers and failing to do sufficient research on the IBalance design.

What About Exactech’s Optetrak System ?

The Exactech device was purportedly flawed from the beginning. Many patients said the company’s Optetrak tibial trays became loose, resulting in early failure, particularly for overweight and obese patients, according to U.S. Recall News.

The publication reported severe side-effects allegedly caused by the Optetrak, including a condition called aseptic lymphocyte-dominated vasculitis-associated lesions, which is diagnosed when a patient develops “tumor-like structures in the skin surrounding the prosthetic,” caused by long-term exposure to metal.

If you’ve suffered knee replacement injuries, you could be eligible to file a knee replacement lawsuit.

Join a Free Knee Replacement Class Action Lawsuit Investigation

If you or a loved one suffered from complications caused by an Arthrex knee implant or an Exactech knee implant, you may have a legal claim. Get help now by filling out the form on this page for a FREE case evaluation.

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This article is not legal advice. It is presented
for informational purposes only.

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