Howmedica faces a new lawsuit alleging that Stryker hip implant defects can lead to early device failure, necessitating revision surgery.

Plaintiff Linda W. filed her lawsuit against Howmedica Osteonics Corp., alleging that Stryker hip implant defects caused early failure of her hip replacement.

Linda says she was implanted with two LFIT V40 Femoral Heads in December 2005. Due to Stryker hip implant defects, the right and left femoral heads were explanted in March 2011 and April 2011, respectively. Linda claims that the manufacturers knew or should have known that Stryker hip implant defects could lead to early implant failure.

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 any clinical studies if they can be proved sufficiently similar to a device on the market already.

Although this speeds up the approval process for many devices and allows the FDA to focus on new groundbreaking technology, plaintiffs claim complications can arise after some devices approved through the 501(k) process are already on the market due to a lack of testing. Linda argues that the lack of testing meant that Stryker hip implant defects 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 hip implant defects 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.

“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 hip implant defects 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 pseudotumor as a result of Stryker hip implant defects, which often resulted in revision surgery.

Linda 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, labelling, instructing and safety evaluations resulting in the products entering the market in a dangerous condition, and remaining on the market with improper warnings”.

Linda accuses the manufacturers of negligence, negligence per se, defective design, manufacturing design, failure to warn, breach of warranties, violation of consumer protection laws, negligent misrepresentation, loss of consortium, 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-10742-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.