A Florida man has filed a complaint against medical device manufacturer Howmedica Osteonics, joining mass litigation over a Stryker hip replacement.

Plaintiff Richard S. joins hundreds of others who have claimed that the defendant’s product, the Stryker LFIT Anatomic V40 Femoral Head and its components, were defectively designed. Defendant Howmedica Osteonics stands accused of negligence, failure to warn, breach of warranty, deceptive trade practices, and violation of consumer fraud and protection laws.

What is a Femoral Head?

The “femoral head” is located at the top of the femur, or thigh bone. It is the round, knob-like protrusion that fits into the hip socket. This is the part of the patient’s anatomy that is actually replaced during hip surgery. The component of the device that is inserted into the femur is known as the “taper lock.”

The specific cause of action in current Stryker Hip lawsuits stems from corrosion and fracturing of the taper lock. This has been happening with the LFIT V40 at an unacceptably high rate, plaintiffs say. When this occurs, revision surgery is invariably required. In the meantime, the patient may suffer loss of motion and debilitating pain due to broken bone as well cobalt and chromium poisoning as shards of the material becomes embedded in the surrounding tissues.

Not The First Stryker Hip Device

The LFIT V40 femoral head was voluntarily recalled by the manufacturer in August 2016 after a number of adverse event reports were received regarding the device. However, this is not the first Howmedica product to be subject to recall.

Three previous products – the Accolade TMZF Plus Hip Stem, the Rejuvenate and the ABG II Modular Neck Stems were also recalled in 2011 and 2012. These devices had similar problems: specifically, the degradation of the components was resulting in tiny bits of toxic metals to become lodged in patient tissues, resulting in a condition known as metallosis, or heavy metal poisoning. This was due to the friction created by the movement of metal on metal. In 2016 Stryker Medical a global settlement with plaintiffs who had sued over those products in the amount of $1.4 billion.

It bears mentioning that the V40 Femoral Stem was approved by the FDA through a questionable process known as “510(k) Premarket Notification.”

By demonstrating that a new product is “substantially equivalent” to a previously approved, or “predicate” device, a medical device manufacturer is able to bypass the usual rigorous testing and clinical studies that are normally required before approval is granted. This, and a drastically lower application fee, saves money for the company. But patient advocates argue the lack of full testing allows dangerous devices to enter the market.

The Current Case

According to his complaint, Richard was implanted with an LFIT V40 on his left hip at the end of September 2014 at Palm Bay Hospital. He says he had begun suffering pain and mobility problems, but did not know the cause until he was advised of the product recall two years later. Blood tests allegedly revealed “excessive levels of chromium and cobalt,” which he attributes to Stryker hip defects.

Richard S.’s Stryker Hip Lawsuit is part of MDL No. 17-md-2768-IT, U.S. District Court, District of Massachusetts.