Patients who have had a knee replacement and a knee implant failure may be suffering due to high-viscosity bone cement failures.
Traumatic injuries, aging, and other issues may require patient to have a medical device implanted in their knee. This is done through a surgery called, a total knee replacement (“TKR”). A TKR involves removing diseased bone. During a TKR, a surgeon replaces the bone with artificial material such as metal. Knee replacement surgery is a significant procedure.
These knee implants are medical devices. They sometimes fail. When they fail, patients generally report pain, instability, joint swelling, irritation, clicking, and grinding in the knee. Some patients with failed knee implants have field lawsuits. They generally alleging the artificial knees are defective. For instance, we have written about the DePuy Knee Replacement Lawsuits previously.
The attorneys at KBA are investigating reports regarding patients who have undergone knee replacement surgery and had to have a revision or removal surgery. Doctors perform revision or removal surgery to modify the artificial knee in some way or to remove it all together. Several things can cause the knee implant to become loose, including infection, and that loosening can require surgery. In some other cases, however, the bone cement may have caused or contributed to the knee implant failure.
The potential role of high-viscosity bone cement.
There may be “aseptic loosening” or “aseptic tibial loosening,” which is “is the failure of the bond between an implant and bone in the absence of infection.” This could be a failure of the bone cement to do its job adequately. Some related research articles published have been published. For example, one study concluded that “cement viscosity does indeed play a role in arthroplasty success.” This is just one study. It is not presented to suggest the risks outweigh the benefits, or that all problems are caused by bone cement. Nonetheless, it could be worth investigating if problems arise or persist. Accordingly, KBA is investigating the role the bone cement in knee replacement failures.
What are potential cases?
There are three kinds of bone cement – low, medium, and high-viscosity. The attorneys at KBA are investigating the failure of some high-viscosity bone cement. Patients can obtain their medical records to identify which cement was used in their surgery. KBA is investigating:
- Cobalt HV Bone Cement (Biomet/DJO Surgical)
- DePuy CMW 1 Bone Cement
- Simplex HV Bone Cement (Stryker/Howmedica)
- SmartSet HV Bone Cement (DePuy (a J&J company))
How did these devices get to patients?
The FDA did not approve these products through its PMA process. See our write-up about how medical devices get to the market. Instead, FDA cleared these medical devices through the 510(k) process. This may mean there will not be preemption arguments available to prevent holding the medical device companies accountable. That has been an issue in recent litigations including in Essure and in the hip litigation.
Patients with failed knee implants may be able to recover damages.
This is some good news in the face of tragedy for people who have had a total knee replacement that failed.The high-viscosity bone cement may be the cause of the failure. If so, there may be a way to recover damages for pain and suffering. In the meanwhile, the most important thing is for patients to discuss issues with their healthcare providers. If bone cement could be an issue, an attorney can investigate a potential claim.