The LFIT V40 Stryker femoral head, made of a combination of cobalt and chromium, was officially recalled by the Stryker company in August 2017.

The admitted problem with the Stryker femoral head revolved around how it locked down onto its stem, the part of a hip prosthetic unit that is implanted into the major bone of the upper thigh known as the femur.

According to the Stryker, makers of the Stryker femoral head, this component had a higher percentage of failure in recipients at the junction of the stem, which can cause instability and numerous problems leading to the need for premature revision surgery.

Hip revision involves removal of the prosthetic and replacing it with another. Since the surgery is so invasive to begin with, the need for a second one can pose even greater risks including loss of bone tissue, leg length discrepancies, and blood clots, just to name a few.

The LFIT V40 Stryker femoral head was created to be used with several potential Stryker stem products, including Accolade, ABG II, Citation TMZF HA, Exeter V40, Hipstar, Meridian PA, Rejuvenate, Reliance PF, and Restoration.

Despite being designed for use with these in-house products, taper lock failure was occurring at an abnormal rate and set off alarm bells for the company.

Issues arising from taper lock failure prior to revision can include swelling in the joint with pain and difficulty ambulating, dislocation, fracture, or bone fragmentation. The body can react to the taper lock failure with tissue reactions that resemble a response to an invading foreign body.

Stryker Femoral Head Lawsuits and Current Developments

Complaints against the Stryker company have been significant since the recall. There have been approximately 180 federal hip implant lawsuits filed regarding the Stryker femoral head. Several other cases are being organized in the State of New Jersey, Superior Court of Bergen County as Multidistrict Litigation (MDL).

According to previous court documents, federal plaintiffs were assigned a deadline of Jan. 12, 2018, to bring in all materials related to their case that presented associated facts.

By adhering to this date, complainants were to be then eligible to have their case considered for bellwether trial purposes. The date was later extended to Jan. 26, 2018.

What is a Bellwether Trial?

A bellwether trial is a common practice in which one lawsuit in an MDL is tried so that other parties can have an idea of how the salient issues will play out. The cases chosen for bellwether status must be representative of the total. Results of bellwether arguments shape settlement negotiations and the way further cases are presented at trial.

The Stryker Company is alleged to have failed to warn the public and medical professionals about the dangers associated with their Stryker femoral head. They stand accused of pushing the hip prosthetic component through the U.S. Food and Drug Administration’s (FDA) 510(k) approval shortcut, relieving themselves of the responsibility of completing proper safety studies on the device.