A knee replacement patient says the bone cement used in some knee implant procedures is defective. She says the cement failed and caused loosening of the implanted device.

Plaintiff Osa G. filed this DePuy lawsuit over problems with a knee implant. The lawsuit was filed against DePuy Orthopedics due to alleged injuries sustained by the plaintiff after receiving a device adhered with the DePuy SmartSet HV bone cement knee implant. Loosening of the device can cause pain, total device failure, and the need for revision surgery.

The lawsuit points out that the plaintiff underwent right sided total knee replacement surgery in August 2016. A bone scan a year later indicated evidence of loosening of the tibial component, which caused a need for revision surgery for the plaintiff. The plaintiff says that she was ever told about the possibility of knee loosening and had to suffer the consequences as a result.

The DePuy lawsuit points out that total knee replacement, also referred to as total knee arthroplasty, is the most commonly performed orthopedic procedure.

The surgery is designed to assist patients who are suffering from decreased joint function and to address pain and bone replacement for those patients who have been severely injured or have experienced a wearing down in their knee. In order for the implant to be installed, cement is used to adhere the parts to the patient’s bone.

Bone cement, Osa explains, is used to attach the components of the artificial knee joint to the femur and the tibia. Bone cement includes a liquid as well as the powder that have to be combined.

The  knee implant lawsuit says the DePuy SmartSet HV bone cement used in the plaintiff’s replacement surgery was a high viscosity cement. The plaintiff points out that the defendant originally received FDA clearance for their product through the FDA’s 510(k) notification process, which means that the defendants did not have to go through the comprehensive testing required for general approval that other new medical devices must go through.

However, many different patients and some academic studies have reported concerns associated with debonding of high viscosity bone cement. The lawsuit points out that this cement sometimes fails as a result of mechanical loosening.

The lawsuit argues that the mechanical loosening of bone cement loosens the attachment between the existing bone and the artificial knee, which ultimately causes complete failure of the device.

Recent studies, according to the lawsuit, point out that mechanical loosening has occurred at much higher rates in patients who were implanted with high viscosity bone cement, including the product manufactured and used by DePuy. A loose artificial knee component can cause wearing away of the bone as well as pain.

The DePuy SmartSet HV bone cement lawsuit is case 1:18-cv-00791 in the U.S. District Court for the Western District of Louisiana.