The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

A Texas woman recently joined the many individuals that have filed Stryker LFIT V40 femoral head lawsuits. She filed her case on March 7, 2017, in the U.S. District Court for the Southern District of Texas, and claims that after receiving a hip replacement with a Stryker femoral head, she suffered serious injuries and had to undergo revision surgery.

Manufacturer Howmedica released an urgent medical device notification to surgeons on August 29, 2016, recalling certain sizes of the LFIT Anatomic CoCr V40TM femoral heads manufactured prior to 2011, because of a higher than expected number of reports of implant failures. The FDA later announced the recall as a “class 2” device recall.

Plaintiff Develops Pseudotumor 7 Years After Implant

According to her complaint, the woman underwent a total hip replacement on October 13, 2008. She had been suffering from degenerative arthrosis in her left hip and was struggling to maintain her mobility. Her surgeon implanted a Trident PSL HA Cluster Acetabular Shell with a Trident X3 Polyethylene Insert, and an Accolade TMZF Plus femoral stem with an LFIT V40 head.

In any hip replacement, the stem goes into the femur or thighbone, and the head is at the top of the stem. It is normally a “ball” shape and fits inside the cup, which is inside the hip socket. The head then allows for rotation in the joint.

The Stryker LIFT V40 femoral heads are made to be used with several femoral stems, including the Plaintiff’s Stryker Accolade TMZF, as well as the Accolade II, the Meridian, and the Citation. The component was supposed to reduce the risk of dislocation while maximizing movement and stability. Unfortunately, post-marketing reports showed that the head had a high risk of “taper lock failure,” which means that it could disassociate from the hip stem, actually breaking off and causing catastrophic hip implant failure.

The plaintiff’s complaint states that about seven years after she underwent the procedure, she started to experience pain and discomfort in her left hip. She went back to the doctor, who performed an MRI evaluation. Results showed that a pseudotumor had developed in the joint.

Plaintiff Undergoes Revision Surgery to Replace Stryker LFIT V40 Femoral Head

A pseudotumor is a mass-forming tissue reaction that develops as a result of two metal components rubbing against one another in a hip implant. Similar to benign tumors, they can be solid tissue or semiliquid masses that create pain and discomfort in the joint, and usually, signal other issues inside the joint such as loosening or tissue damage and necrosis.

Because of this finding, the plaintiff’s surgeon recommended revision surgery. The procedure took place on January 16, 2016. During surgery, the surgeon found the pseudotumor, as well as “significant metallosis inside the hip joint.” Metallosis refers to metal corrosion or fretting between the metal components and around the joint tissues. In addition, trunnionosis existed around the implant, which is corrosion specifically between the metal surfaces at the head-neck connection, or “taper lock” area.

Finally, the surgeon noted osteolysis around the proximal femur, which means bone damage and potential bone loss in the thighbone. To address the problems, the surgeon removed the LFIT V40 cobalt chrome femoral head and replaced it with a ceramic femoral head.

The plaintiff blames manufacturer Howmedica for failing to provide adequate warnings about the risks associated with their femoral head, for failing to properly investigate problems with the component, and for failing to provide timely reports to the FDA about the adverse effects associated with the device. She brings counts of negligence, and defective design and manufacturing, and seeks actual damages in excess of $75,000.

Comments are closed.

Of Interest