Plaintiffs Shondra B. and Eric B. are two of the latest Stryker hip replacement patients to file a lawsuit over the Stryker LFIT V40 femoral head.

These plaintiffs, among many others, argue that Stryker’s femoral head was defective and that manufacturers knew or should have known about the dangers but failed to disclose them.

The Stryker LFIT V40 femoral head argues that the devices intended to replace diseased or damaged natural anatomy for impacted patients and that the devices, which are frequently recommended for patients requiring total hip arthroplasty, are defective.

The FDA approval of the LFIT V40 first came in April 2001, using the fast track section 510(k) approval of the Food, Drug and Cosmetic Act. Medical devices that are approved under section 510(k) do not require any additional clinical studies to gain FDA clearance, meaning that it does not have to be tested on human beings prior to being placed on the market.

The approval for marketing the device came in August of 2006.

Stryker Lawsuit Complaints

The plaintiffs in the Stryker LFIT V40 femoral head lawsuit argue that the device is prone to a number of serious and painful side effects that can impede a patient’s mobility and overall health.

Some of the side effects reported in the lawsuit over the Stryker LFIT V40 include corrosion, fretting, destruction of tissue, development of fluid collections, pseudo tumors, the necessity for revision surgery, and the release of metal ions or metal debris into the body.

The plaintiffs allege that the device makers knew or should have known about the risks of painful side effects and breakdown of the Stryker LFIT V40 device, but chose to push this item to market, leaving patients to pay the price in significant injuries and painful side effects.

Many other plaintiffs have filed a lawsuit over issues with Stryker hip replacements with the Stryker LFIT V40, arguing that these defective devices put patients at risk.

The breakdown of metal ions inside a hip device can cause a condition known as metallosis. A patient might not know that they are suffering from metal poisoning in the blood until the symptoms are advanced.

Getting a hip replacement is a major commitment, given the possibility of side effects and infections. Most patients who go through a total hip replacement are suffering daily pain from their natural hip and might not be able to live their life normally without replacement surgery. A revision of a current hip surgery, however, puts the patient back into the pool of risks incurred from procedures and can lead to additional side effects and costs.

For those that suffered past injuries, Stryker already settled hundreds of claims.

The Stryker LFIT V40 femoral head lawsuit is Case No. 1:18-cv-01441 in the U.S. District Court, Western District of New York.