Faulty knee cement has been allegedly causing knee replacement patients to suffer serious device complications like aseptic tibial loosening, forcing many of them to undergo revision surgery.

Patients opted for the total knee replacement to repair damage caused by degenerative bone disease or other injuries, but a recent study has found that these patients may face an increased risk of device failure due to faulty knee cement.

According to the National Center for Biotechnology Information (NCBI), injury reports have indicated serious problems with knee cement. In 2016, researchers had reviewed 13 cases in which the knee implant had either allegedly failed to properly bond or suddenly debonded from the edge of the shin bone.

Researchers believe the high viscosity cement (HVC) used in these prosthetics may be the cause, as patients who underwent similar procedures with non-HVC bonding agents experienced no such problems.

In addition, the NCBI noted a 2013 study in which 3,048 total knee replacement procedures had been performed, with only nine failures. Each of these failures reportedly involved HVC knee cement.

Overview of Knee Cement Problems

Knee replacements have been frequently performed in recent years, as the patient population in the United States continues to need new options for prosthetics.

In fact, according to the Arthritis Foundation, total knee replacement surgeries are one of the most commonly performed surgeries. Estimated statistics place the number of these procedures at over 3 million by 2030. With many implants, bone cement is a common piece of the procedure.

Also called epoxy, bone cement is used to attach knee implant components to the femur and tibia. Bone cement consists of a powder and liquid that bonds when mixed, and is supposed to be a reliable method in securing knee replacement systems.

There are three levels of viscosity when categorizing the bone cement used for knee replacements, including low, medium, and high. Of the three, according to the Orthopedic Research Society, low or medium viscosity bone cement may be more effective bonding agents than high HVC products.

Surgeons sometimes opt for high viscosity knee cement because it is reportedly easier to work with, takes less time to mix together, and sets quickly. However, recent research has suggested HVC knee cement may not properly bond to the bone.

It is believed that the higher viscosity levels may not provide sufficient bond strength in the knee replacement system or the bone. One of the major complications patients can suffer from HVC knee cement complications is aseptic tibial loosening–aseptic meaning without any infection.

Tibial loosening happens when the knee cement may fragment or the bond is broken, with this problem typically occurring where the implant is attached to the tibia and sometimes femur. Patients who suffer complications related to knee cement replacement implant failure may experience a number of painful symptoms including but not limited to:

• Persistent Pain
• New Chronic Pain
• Instability
• Swelling
• Device Loosening
• Limited Range of Motion

Manufacturers of HVC bone cement had received fast track approval from the FDA, claiming the material was “substantially equivalent” to similar bonding agents on the market. However, the allegedly defective nature of HVC bone cement has already spurred legal action from patients who have had to undergo revision surgery.