Patients who have had knee replacement surgery have reportedly experienced aseptic tibial loosening due to failure of the cement used to secure the components. Specifically, this cement is the special adhesive, or “glue” used to fix the knee implant to the bone.

Some components of knee implants are attached to the actual leg bones, using a combination of screws and adhesive. When the adhesive fails to do its job, the result can be chronic pain, swelling and limited mobility. In some cases, the toxic substances used to make the adhesive can enter the tissues and bloodstream, causing serious reactions and even death.

What is Aseptic Tibial Loosening?

The word “aseptic” indicates the absence of a bacterial infection.

When the bond between the prosthetic implant and the bone surface comes loose, it can be due to a number of causes. Most often, it is due to wear and tear on the mechanism; however, bacterial infection can also cause an artificial joint replacement to fail prematurely.

When done properly, a knee replacement is good for up to 20 years for the vast majority of patients who undergo the procedure. However, when the initial fixation of the prosthesis is inadequate, it can result in premature failure even when no bacterial infection is present – usually within 3 years or less.

What Types of Bone Cement are Used?

When a joint prosthesis is cemented in place, the surgeon may use one of three varieties, which are classified according to viscosity. Many surgeons prefer to work with the high viscosity, or thicker bone adhesives; they are more easily mixed and have a shorter setting time. However, research indicates that “high-viscosity cement” (HVC) is less reliable and more likely to fail because it bonds less securely to the bone surface.

High-viscosity bone cement products that have been associated with aseptic tibial loosening include:

• Cobalt HV Bone Cement

• DePuy CMW 1 Bone Cement

• Simplex HV Bone Cement

• Smart Set HV Bone Cement

The Smart Set HV Bone Cement, manufactured by Johnson & Johnson subsidiary DeDuy Orthopedics, reportedly underwent virtually no clinical testing prior to its approval by the FDA. The company used a controversial process known as 510(k) Pre-Market Notification, which allows a medical device manufacturer to bypass the usual stringent testing requirements if the new product is substantially equivalent to a previously FDA-approved product (known as a “predicate”). This loophole may have resulted in the approval and marketing of many defective and dangerous products.

Aseptic Tibial Loosening Lawsuits

A number of injury lawsuits have been filed over the past several years over bone cement failure and related complications. Law firms are currently reaching out to people who have undergone knee replacement surgery and have experienced premature failures of these implants because of aseptic tibial loosening. If you have experienced such an injury, you may be eligible to file a complaint and seek compensation for medical expenses, lost income and pain and suffering.