A Stryker LFIT lawsuit has been filed by a woman who underwent a left hip total replacement surgery in October 2003 and a subsequent hip revision surgery in May 2010.

Plaintiff Diane J. was implanted with the Stryker LFIT Chromium Cobalt V40 Femoral Head during her 2010 revision surgery. Soon after, she says, she began to endure “progressive pain, loosening of the hip, inflammation and soreness around the implant, and severe discomfort.”

In February 2017, Diane underwent another revision surgery to remove the failed LFIT component. Doctors found “device corrosion, damage to tissue surrounding the implant, and metallosis,” also known as metal poisoning. After these findings she filed her Stryker LFIT lawsuit.

Stryker LFIT Lawsuit Notes Recall

Stryker sent an “Urgent Medical Device Recall Notification” letter to surgeons on Aug. 29, 2016 regarding the Stryker LFIT V40 femoral heads made before 2011. The Stryker LFIT lawsuit alleges the recall notice included claims that Stryker “had received higher than expected complaints describing incidences of harm secondary to taper lock failure for specific lots of LFIT V40 heads.”

The recall notice warned of potential problems such as the femoral head dislocating from the hip stem and excessive metal debris, but the letter did not give doctors new instructions on how to properly monitor patients.

A simple blood test can let patients know if they have elevated levels of metals in their blood, which would indicate metallosis and device corrosion.

The Stryker LFIT lawsuit says, “There are potentially several hundred thousand individuals with defective LFIT V4- heads whose hips are leaching toxic levels of cobalt and chromium into their bloodstreams, completely unaware that their hips are corroding.”

Stryker had similar problems with its Rejuvenate and ABG II modular hip implant systems that were recalled in 2012. Those systems used the same TMZF titanium metal in the femoral stem, and the modular necks of both systems were made of chromium and cobalt. Their recalls were due to fretting and corrosion at the taper junction where the different metals were scraping against each other.

The metal-on-metal design cause friction that results in small metal shavings. When these tiny particles fret away, the surrounding tissue can become affected and react with inflammation and fluid retention. In addition, surrounding tissue can die and metal poisoning can set into the bones and the blood stream.

Stryker LFIT Lawsuit Alleges Patients Were Virtually Clinical Trial Subjects

Diane’s Stryker LFIT lawsuit says that the company failed to adequately test the LFIT V40.

The claim states, “Prior to marketing the LFIT V40, Defendants failed to conduct anything other than simple, basic bench testing so that when manufactured and marketed, patients became, in essence, Defendants’ first clinical trial.”

The Stryker LFIT lawsuit also contends that the LFIT V40 femoral head was “poorly designed or manufactured and did not ‘fit’ as intended.”

In addition, Stryker stands accused of designing or manufacturing the LFIT V40 in a way that did not allow the component to maintain structural integrity once it was implanted in the body with dissimilar metal stems.

The Stryker LFIT Lawsuit is Case No. 3:17-cv-30056-IT in the U.S. District Court for the District of Massachusetts.