Bone Cement Lawsuit
Certain cement used in knee replacement surgery has caused many Americans to undergo revision surgery, as the cement fails to stay bonded to the bone.
Have you had a knee replacement revision surgery because of problems with bone cement?
Patients who had knee replacements have had to undergo revision surgery after their knee implant failed due to problems with the bone cement used. Knee implant failure is usually detected by signs of persistent pain, new chronic pain, instability, loosening of the knee implant, swelling and decreased range of motion.
Bone cement products that have been linked to failure are: DePuy CMW 1 Bone Cement, DePuy SmartSet HV Bone Cement, Stryker/Howmedia Simplex HV Bone Cement, and Biomet/DJO Surgical Cobalt HV Bone Cement.
DePuy is a subsidiary of pharmaceutical giant, Johnson & Johnson. A recent lawsuit from 2018 alleged DuPuy’s SmartSet cement caused the patient’s knee implant to loosen. This resulted in revision surgery to remedy the previous surgery, only a year after it was performed.
Knee replacement surgery is already a major task to undergo, usually requiring weeks and months of physical therapy. The last thing anyone wants is complications with their prosthetic not staying in place.
Cement Used in Knee Replacement Surgery
Prosthetic knee replacement products come in either cemented or cementless. In this case, cemented products allow the implant to attach to the natural bone of the patient. There are three types of cement: low, medium, and high-viscosity cement (HVC).
Surgeons sometimes prefer using HVC because it’s easier to work with and takes less time to mix and set. However, researchers claim it doesn’t bond to the bone and is prone to failure.
Bone cement complications occur for two reasons: bone cement implantation syndrome and aseptic loosening.
Bone Cement Implantation Syndrome is the result of toxins in the cement reacting negatively in the body. Bone cement implantation syndrome is very serious and life-threatening. BCIS can happen fairly quickly during surgery when the cement is applied. It happens when bone marrow, fat, and/or fragmented bone cement get into the bloodstream.
There is also concern that it can make its way into other surrounding tissues, such as veins and nerves, leading to nerve pain and other side effects. This could happen when the cement is applied with a needle during surgery.
Symptoms of BCIS include:
- Deficiency (hypoxia)
- Low blood pressure (hypotension)
- Loss of consciousness
- Blood clots
- Increased pulmonary vascular resistance
- Cardiac arrhythmias
- Cardiac arrest
- Fat/marrow emboli (globules released into the bloodstream)
Aseptic loosening does not include infection, but it can cause major issues in the recipient. The loosening typically occurs when the implant has been attached to the tibia bone more than the femur. It is also caused by fragmentation or a disconnecting of the bond with the bone.
In 2016, a report published by the National Center for Biotechnology Information (BNBI) observed 13 cases of knee implant failure. This included knee implants failing to stay attached to the cement, or the implant was debonded from the bone. Researchers found the common issue with high-viscosity cement. Conversely, implants that used low or medium viscosity did not show signs of debonding.