Howmedica faces a new lawsuit from a consumer alleging Stryker metal hip complications led him to need revision surgery.

Plaintiff Brian Y. recently filed a lawsuit against Howmedica Osteonics Corp., alleging that Stryker metal hip complications caused him to need revision surgery.

According to his complaint, Brian was implanted with the LFIT C-Taper Femoral Head in August 2009 during a right hip replacement. The implant was removed shortly after in December 2009. In April 2011, he was implanted with the LFIT Anatomic CoCr V40 Femoral Head. However, Brian alleges that in May 2016, he had to undergo further surgery and have the femoral head explanted.

In 2001, the LFIT V40 femoral head was approved by the U.S. Food and Drug Administration (FDA) through the 501(k) process. The 501(k) approval process allows devices to be approved without full clinical studies if they can be proven similar to a device already approved. Many companies use this process to gain approval quicker since it speeds up the approval process for many devices and allows the FDA to focus on new groundbreaking technology.

However, critics say that some devices approved through the 501(k) process develop complications after being on the market due to a lack of testing. The lawsuit argues that a lack of testing meant that Stryker metal hip complications were not found until after the device was implanted and failed in numerous consumers.

The LFIT V40 femoral heads are made of cobalt-chromium which is allegedly prone to Stryker metal hip complications including fretting, corrosion, and the production of metallic debris. Metal debris in the implant site can cause an adverse tissue reaction, tissue death, inflammation, stiffness, restricted range of motion, pain, and more. These problems allegedly increase the chance of implant failure, causing many patients to undergo revision surgery to fix the problems.

“Frequent findings during revision surgery are the presence of turbid, milky fluid collection, large pseudotumor formation, discolored or friable soft tissue and bone, bone and soft tissue necrosis, and detachment or tearing of muscle,” the lawsuit states.

In 2016, Stryker metal hip complications prompted the FDA to issue a device recall for certain lots of LFIT V40 femoral heads manufactured before 2011. Patients had reported pain, disability, destruction of tissue, fluid collection, and pseudotumors, which often resulted in revision surgery.

Brian claims that the manufacturers should have properly tested the device before releasing it onto the market and aims to hold them accountable for medical bills, pain and suffering, and more.

“Defendants breached their duty of care,” the lawsuit states. “[Their] conduct demonstrates Defendants’ failure to exercise reasonable and appropriate care in the testing, designing, manufacturing, marketing, labeling, instructing and safety evaluations resulting in the products entering the market in a dangerous condition, and remaining on the market with improper warnings”.

Brian accuses Howmedica of negligence; strict products liability – design defect; strict products liability – manufacturing defect; strict products liability – failure to warn; breach of warranties; violation of consumer protection laws; negligent misrepresentation; and unjust enrichment.

The lawsuit seeks compensatory damages, statutory damages, restitution, disgorgement, court costs, and attorneys’ fees.

The Stryker Hip Lawsuit is Case No. 1:18-cv-10853-IT and is part of the Stryker Hip MDL, In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, Case No. 1:17-md-02768-IT, in the United States District Court for the District of Massachusetts.