Howmedica Osteonics Corp., and its subsidiary, Stryker Orthopedics, face a lawsuit that blames the companies for harm related to their Stryker Accolade hip implant.

Plaintiff Joyce U., a California resident, alleges that she suffered harm from the defendant’s developing, manufacturing, and distributing of the Stryker Accolade hip implant. She asserts that the defendants should have known that the medical device was defective and that it could cause “fretting and corrosion at the junction between the femoral stem and the femoral head.”

The Stryker Accolade hip implant lawsuit contends that such fretting and corrosion can cause harm such as loss of movement, dislocation, significant pain, disability, and personal injury. These injuries, moreover, may only be relieved through revision surgery.

According to the Stryker Accolade hip implant lawsuit, Howmedica and Stryker have both misled the public and other healthcare professionals that the medical device was safe for use and that the product was effective for use in total hip arthroplasty procedures.

Stryker Accolade Hip Implant Parts

In a total hip arthroplasty procedure, the Accolade TMZF Hip Stem and Anatomic V40 Femoral Head are used to help reconstruct the hip joint that has been worn out due to avascular necrosis, fracture, rheumatoid arthritis, or osteoarthritis.

The hip joint is a ball-and-socket joint that connects the femur bone in a patient’s thigh to the pelvis. The Stryker Accolade hip implant includes the insertion of a femoral head that is manufactured from metal, and a femoral stem that is also manufactured from metal. This metal-on-metal design has been linked to corrosion, fretting, and generation of metallic debris that can circulate in a patient’s blood.

According to the Stryker Accolade hip implant lawsuit, “fretting and corrosive debris in a joint area can lead to multiple complications, including but not limited to, pain, adverse local tissue reaction, pseudotumors, osteolysis and/or spontaneous dissociation- fracture of the femoral neck or trunnion of the prosthesis.”

Additionally, the plaintiff says the Stryker Accolade did not go through a rigorous FDA premarket approval process. Instead, the Stryker Accolade hip implant lawsuit states that these medical devices was approved on the basis that, “under section 510 (k) of the MDA, they were ‘substantially equivalent’ to older hip implant devices that defendants sold and implanted prior to the enactment of the MDA in 1976.”

As a result, the Stryker Accolade hip implant lawsuit states that the medical device approval was granted without any clinical or non-clinical trials or FDA review. The FDA did not review the medical device for safety and effectiveness the same way it does for completely new devices.

The Stryker Accolade Hip Implant Lawsuit is Case No. 2:17-cv-04175, in the U.S. District Court for the Central District of California.