A woman has filed a lawsuit after she allegedly was injured by hip implant components covered in the Stryker LFIT V40 recall.

Plaintiff Juniper M. says she had the Stryker LFIT Anatomic CoCr V40 Femoral Head and the Accolade TMZF Femoral Stem implanted in her right hip in April 2006.

She says that after suffering severe injuries allegedly due to the implant, she had the LFIT V40 femoral head explanted in November 2016.

Howmedica received FDA approval for the femoral head in August 2006. The component was designed to fit with a variety of stems through the use of a unique cone-within-a-cone adapter known as a Morse taper, which relies on dissimilar angles to secure fixation.

According to the Stryker LFIT V40 recall lawsuit, the alleged defective design of the V40 tapers “allow the head to move on the stem which promotes corrosion and fretting.”

In August 2016, the Stryker LFIT V40 recall was issued after a large number of reports of component failure. Complications associated with the recalled parts included:

• Device fretting
• Device corrosion
• Metal ion release
• Metal debris
• Pain
• Tissue death
• Excess fluid collection
• Pseudotumors
• Revision surgery

Stryker LFIT V40 Recall Reasons

The Stryker LFIT V40 femoral head was marketed with a variety of femoral stems, including the one used in Juniper’s surgery. The Accolade TMZF is made of a titanium, molybdenum, zirconium and iron alloy that, according to the lawsuit, “causes a significant amount of toxic corrosion when it is implanted with CoCr (cobalt/chromium), like the LFIT V40 Femoral Head.”

The lawsuit alleges Stryker knew or should have been aware that the dissimilar metals would cause fretting issues.

When the metals fret, the tiny shards are unable to leave the body, so they become embedded into nearby tissue. In an effort to expel the irritants, the body reacts by becoming inflamed and by sending fluid to the site in an effort to flush away the metal pieces.

The inflammation and fluid retention can become a pseudotumor, a painful knot of fluid and inflammation that mimics a tumor. Eventually, poisoned tissue will die.

Metal ions also escape and enter the blood stream. Most patients are unaware they are suffering from metal poisoning, also known as metallosis, until a blood test reveals elevated levels of cobalt and chromium.  These toxic metals can cause cancer, degenerative heart disease, cardiomyopathy, thyroid dysfunction and impaired kidney function.

The Stryker LFIT V40 recall became necessary because of a “higher than expected” number of taper lock failure reports, said Howmedica. Among the “potential hazards” Howmedica associated with taper lock failure are:

• Femoral head dislocating from the hip stem
• Fractured hip stem trunnions
• Excessive metallic debris
• Excessive wear debris

If you or someone you love has suffered from failure of hip replacement components covered by the Stryker LFIT V40 recall, you could be eligible for compensation through legal means.

The Stryker LFIT V40 Recall Lawsuit is Case No. 1:18-cv-11644-IT and is part of the Stryker LFIT V40 MDL, In re: Stryker LFIT V40 Femoral Products Liability Litigation, MDL No. 2768, in the U.S. District Court for the District of Massachusetts.