A new lawsuit indicates that DePuy knee replacement SmartSet GHV bone cement is dangerously defective, resulting in mechanical loosening of implants, premature failure, and additional risky surgical procedures.
Osa Green filed the complaint against Johnson & Johnson and its DePuy unit this past month in the Western District of Louisiana. Green alleges that the DePuy SmartSet GHV Bone Cement is not only defective but incredibly dangerous. Furthermore, she indicates that the manufacturers concealed these defects to protect the product’s profitability. Green maintains that she would not have consented to the bone cement for her knee replacement surgery if the manufacturers had disclosed known problems with the product.
In August 2016, Green underwent right total knee replacement surgery. During the procedure, she received a DePuy PFC Sigma knee replacement system. Her surgeon used DePuy SmartSet Bone Cement to bond the components together. As a result of the defective nature of the bone cement, Green soon began experiencing severe, chronic pain, instability, discomfort, and difficulty walking.
Green claims that the asceptic loosening of the bone cement caused the implant to fail prematurely. By August 2017, a bone scan showed that the tibial baseplate was loosening. A month later, she had to undergo revision surgery. However, her lawsuit indicates that revision surgery has significantly lower success rates with much higher risks.
“Unfortunately, a failed total knee prosthesis often causes severe bone loss,” the lawsuit states. “Therefore, revision surgeries on a failed total knee due to loosening often require reconstruction of the severe bone loss.”
“The success rate of a revision surgery is much lower than that of the initial total knee replacement and the risks and complications are higher, including limitations in range of motion, the ability to walk, and even death,” the lawsuit continues.
DePuy SmartSet GHV Bone Cement Defects
DePuy SmartSet GHV Bone Cement is part of a class of bone cements known as high viscosity (HV) cements. Some studies have suggested that these cements are less effective than low or medium viscosity cements. The lawsuit cites a Journal of Anthroplasty study’s findings that HV bone cements, like SmartSet GHV, are causing tibial component debonding even in implants that are normally reliable.
“The primary reason the SmartSet GHV Bone Cement fails is mechanical loosening. The mechanical loosening is caused by a failure of the bond between the tibial baseplate at the implant-cement interface,” the lawsuit states. “Mechanical loosening means that the attachment between the artificial knee and the existing bone has become loose. Such loosening will eventually result in failure of the device.”
When bone cement begins to fail, the knee replacement components loosen considerably and can cause extreme pain and loss of mobility, as well as wear away the bone. This continues until the pain becomes unbearable, or the device fails taking knee function along with it. Consequently, most decide to undergo revision surgery to replace the implant entirely.
Tibial baseplate loosening is familiar ground for DePuy as it has affected numerous of its other knee implants. This includes the company’s DePuy Attune Knee that is the subject of hundreds of lawsuits over common catastrophic implant failures. In 2016, the Journal of Knee Surgery published a study, noting a spike in DePuy Attune Knee loosening and failures with concerns directed at problems at the implant-cement interface.