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Bone cement has been used for decades to help join artificial joints to bone. It can be necessary given the pressure placed on joints in order to keep the implants in place over time.
However, certain bone cements have been linked with serious knee replacement loosening symptoms, causing some to undergo revision surgery due to device failure.
Types of Bone Cement
There are a variety of kinds of bone cement used in knee implants: low, medium, and high viscosity, determined by the cement’s properties. High viscosity bone cement specifically is the type at issue. These high viscosity bone cements, from a number of manufacturers, are being targeted in this investigation:
- Cobalt HV Bone Cement (Biomet/DJO Surgical)
- DePuy CMW 1 Bone Cement (NOT CMW 2 or CMW 3)
- Simplex HV Bone Cement (Stryker/Howmedica)
- SmartSet HV Bone Cement (DePuy)
Defective Bone Cement
Unfortunately, these high viscosity bone cements have been linked with knee replacement loosening symptoms. Defective bone cement is associated specifically with aseptic tibial loosening—that is, loosening that involves no infection.
Aseptic loosening can occur when bone cement fragments, or when the bond to the bone is suddenly broken. Usually, this means that the implant is left attached to the tibia bone, but has detached from the femur. A 2016 study found that these issues appeared with the use of high viscosity bone cement rather than low or medium viscosity versions.
Indeed, a growing number of patients who have undergone knee replacement surgery are reportedly experiencing device failure within three years of their surgery, allegedly due to defective bone cement.
Knee replacement loosening symptoms caused by defective bone cement may include persistent pain, new chronic pain, instability, swelling and decreased range of motion.
Lawsuit over Defective Bone Cement
A Louisiana plaintiff filed a lawsuit in June of this year, alleging that the bone cement used to attach her artificial knee joint—SmartSet HV Bone Cement, manufactured by DePuy—caused her to suffer severe knee replacement loosening symptoms.
The plaintiff, Osa G., says she underwent total knee replacement surgery in her right knee on Aug. 25, 2016. However, she says she soon began experiencing knee replacement loosening symptoms including pain, discomfort, and difficulty walking.
Almost exactly a year after implantation, Osa says a bone scan showed evidence of device loosening. A month later, Osa underwent revision surgery to alleviate the knee replacement loosening symptoms. This time, a non-HV bone cement, Simplex P Bone Cement, was used for component bonding.
Osa points out that SmartSet HV Bone Cement never underwent the regular FDA clearance process, and instead was fast-tracked under the 510(k) review process, meaning that it had been shown to be substantially equivalent to approved products already on the market.
The lawsuit, however, claims that SmartSet HV Bone Cement is actually less effective than previous iterations, and even more prone to failure, resulting in knee replacement loosening symptoms.
Osa filed her lawsuit over knee replacement loosening symptoms on June 13, 2018, in the U.S. District Court for the Western District of Louisiana.
Filing a Bone Cement Lawsuit
If you or a loved one have suffered from knee replacement loosening symptoms after undergoing knee implant surgery and have either had a revision surgery already or such a surgery is scheduled or recommended due to defective bone cement, you may be able to file a lawsuit and pursue compensation.
While filing a lawsuit cannot take away the pain and suffering caused by knee replacement loosening symptoms, it can at least help to alleviate the financial burden incurred by medical expenses and lost wages.
The Knee Replacement Loosening Symptoms Lawsuit is Case No. 1:18-cv-00791-DDD-JPM, in the U.S. District Court for the Western District of Louisiana.
If you or a loved one underwent revision knee replacement surgery or your doctor is recommending revision surgery three years or less after the initial implant and a bone cement was used, you may qualify to file a knee replacement revision surgery lawsuit. See if you qualify by filling out the free form on this page.
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