A man has filed a Stryker LFIT hip implant system lawsuit after he had to endure revision surgery less than three years after implantation.

Plaintiff Jack F. claims he received an LFIT (Low Friction Ion Treatment) Anatomic CoCr V40 Femoral Head and a Secur-Fit Femoral Stem in his right hip in November 2014. The LFIT Femoral Head was removed in June 2017.

Jack alleges he suffered injuries as a result of the device implantation, the device performance and the device explantation. His wife is also a plaintiff, raising a claim for loss of consortium, or loss of a partner and active companion.

Stryker is accused of negligence and of knowingly distributing a defectively designed product. The medical device company allegedly should have known that the Stryker LFIT hip implant system was prone to cause problems, including metal poisoning.

Stryker LFIT Hip Implant System Fraught with Problems

The Stryker LFIT MDL explains that the term “V40” refers to the “angular mismatch between the trunnion on the femoral stem and the female taper in the bore of the chrome cobalt head.”

Because the angles are not similar, they are “press fit” and the joint relies on the differences in the angles to keep the parts in place. Stryker is the only company that currently makes the V40 taper design, which plaintiffs claim has led to catastrophic failure.

According to plaintiffs in the MDL, excessive wear and poor design lead to corrosion and, eventually, to Stryker LFIT hip implant system failure. In some extreme cases, the motion-induced corrosion has reportedly led to the femoral head falling off the femoral stem.

Even though Stryker promoted the LFIT V40 femoral heads as consisting of a proprietary alloy that resisted corrosion and fretting, the LFIT V40 actually causes “extreme and unusual amounts of corrosion and wear when used with any femoral stem compatible with the LFIT V40 head,” plaintiffs claim.

The problem as stated in the complaint is that the LFIT femoral head is made of a chrome and cobalt alloy, which may fret away tiny pieces of metal as the hip joint moves. This metal debris can cause physical irritation to nearby tissue, but as the metal ions leach into the blood stream, tissue necrosis (death) can occur. A blood test can determine if a patient is suffering from metal poisoning, also known as metallosis.

Stryker is accused of knowing the LFIT V40 head’s materials would increase the risk of corrosion, despite marketing materials stating the risk would decrease.

Moreover, when the Stryker LFIT hip implant system includes both the LFIT V40 femoral head and the Stryker Secur-Fit femoral stem, the risk of metal debris allegedly increases due to the differing metals rubbing against each other. Stryker had claimed that when used together, the parts allowed for maximum hip movement with resistance to dislocation.

Although Stryker claimed its alloys were superior, researchers have noted for years that both fretting and corrosion are accelerated when differing metals wear against each other. The Stryker LFIT hip implant system was heavily marketed based upon the purported superiority of the alloys.

The Stryker LFIT Hip Implant System Lawsuit is Case No. 1:18-cv-10460-IT, and is part of the Stryker LFIT MDL, In re: Stryker LFIT V40 Femoral Head Products Liability Litigation, MDL No. 2768, in the U.S. District Court for the District of Massachusetts.