Although knee replacement failure may be associated with implant defects, problems with surgical bone cement may also contribute to problems.

During knee replacement surgery, bone cement is often used to help attach the implant to the natural bone. Bone cement comes in three viscosities: low, medium, and high. High viscosity bone cement is preferred by some surgeons because it takes less time to mix and less time to set.

Although high viscosity bone cement is a popular choice among surgeons, researchers claim that the cement can lead to high rates of knee replacement failure because it does not bond with the bone well enough.

In 2016, a knee replacement report published by the National Center for Biotechnology Information (BNBI) showed that high viscosity bone cement was linked with tibial loosening in 13 cases. This type of loosening, when it is not associated with an infection, is called aseptic loosening.

Researchers linked the loosening with high viscosity bone cement after they realized that implants which used low or medium viscosity bone cement were not displaying signs of debonding.

Bone cement problems may also include a life-threatening side effect known as bone cement implantation syndrome. This condition occurs when pressure causes bone marrow, fat, or fragmented pieces of bone cement to enter the bloodstream.

This can lead to serious complications including hypoxia (lack of oxygen), hypotension (low blood pressure), increased pulmonary vascular resistance, cardiac arrhythmias, cardiac arrest, blood clots, fat/marrow emboli (fat or marrow globules that are leased into the bloodstream), and more.

Bone cements that may lead to knee replacement failure include:

• Cobalt HV Bone Cement (Biomet/DJO Surgical)
• DePuy CMW 1 Bone Cement
• Simplex HV Bone Cement (Stryker/Howmedica)
• SmartSet HV Bone Cement (DePuy)

Lawsuits have already been filed regarding the issue. In 2013, a lawsuit was filed by a woman alleging that the DePuy CMW 1 Gentamicin bone cement used in her knee replacement surgery failed to bond correctly, leading to a loosening of the tibial component.

To resolve the knee replacement failure, she allegedly required revision surgery only two and a half years after her initial knee replacement surgery.

Another bone cement lawsuit was filed against DePuy more recently in June 2018. This knee replacement failure lawsuit claimed that the use of SmartSet HV Bone Cement caused the loosening of the plaintiff’s knee implant.

The SmartSet HV Bone Cement was allegedly approved through the U.S. Food and Drug Administration (FDA) fast-track approval process. This allows medical devices to be approved if they are similar enough to devices which are already approved and on the market.

DePuy allegedly claimed that the SmartSet HV Bone Cement was similar to the DePuy CMW 1 Gentamicin Bone Cement and the Simplex P bone cement made by Stryker. However, the knee replacement failure lawsuit claims that the SmartSet HV Bone Cement is “less effective, and more prone to failure, than the previously-approved bone cements.”

The plaintiff argues that DePuy was allowed to release a defective product onto the market, which lead the plaintiff to need revision knee surgery around a year after initial surgery.

Use of Bone Cement

Doctors have increasingly turned to use of bone cement in joint replacement surgeries because of the advantages in doing so. First of all, doctors can decrease the risk of post-surgical infection because a small amount of antibiotic materials can be added to the bone cement during the course of the surgery.

Bone cement might seem like the simplest or even the most effective solution for modern surgeries, but it can also cause unnecessary side effects and problems for some patients if the cement doesn’t work as intended.

According to Arthritis Health, another major benefit to use of bone cement in joint replacement surgeries such as those involving a knee is that the bone cement sets quickly. The bone cement should set within 10 minutes of application so that the patient and surgeon should feel confident that the prosthetic is firmly in place.

Unfortunately, as many news reports and adverse event reports have detailed, many consumers have experienced challenges with bone cement and have felt that their prosthetic has gotten loose relatively quickly after the surgery.

The final major benefit for using bone cement is that it enables the doctor to connect prosthetic components in the joint to a bone that may be suffering from osteoporosis.

Sadly, bits of cement can break off and bone cement can degrade over time in addition to some of the other negative issues associated with the use of bone cement. Despite its popularity, certain patients may have to undergo a replacement surgery due to the issues of bone cement breakdown.