A woman has filed a Stryker V40 femoral head lawsuit against Howmedica Osteonics Corp., alleging her left hip was implanted with a defective device.

Plaintiff Carol C. alleges she received a hip implant in October 2006. Her doctor implanted the Stryker V40 femoral head and the Accolade hip stem. According to Stryker’s literature, the hip stem was made to be used with the V40 femoral head.

According to Stryker’s marketing materials, the Accolade stem was designed to create a better range of hip motion, increase stability, and decrease the risk of dislocation.

More than a year after her left hip implantation, Carol says, she began experiencing pain and discomfort in the area of the device. Tests revealed no signs of infection, but blood tests revealed metal poisoning, also known as metallosis.

With her pain worsening, Carol claims, she finally had to undergo revision surgery in January 2015. Her doctor found significant metallosis and soft tissue damage. She also had suffered severe trunnionosis, which is the wearing of the area where the femoral head and hip stem meet.

Stryker V40 Femoral Head Issues Were Predictable

According to the Stryker V40 femoral head lawsuit, the August 2016 issue of the Journal of Bone and Joint Surgery published an investigative article that reported five cases of Accolade stem/V40 head combinations that failed when the stems fractured.

“Specifically, it was reported that there was extensive corrosion in the V40 head and Accolade stem that was so significant the stem actually fractured at the stem/head juncture,” explains the Stryker V40 femoral head complaint.

The corrosion between the head and stem, which were both made of different titanium alloys, became so significant that pieces of metallic debris became embedded in the soft tissues surrounding the hips. The corrosion led to the stem dislocating from the head.

After that report was published, Howmedica issued a recall stating that certain lots of Stryker V40 femoral heads were “potential hazards” that could lead to:

• The femoral head to dislocate from the hip stem
• Fractured hip stem trunnions
• Excessive metal debris
• Excessive wear debris

The recall notice allegedly did not provide information regarding the cause of the failures, nor did it instruct surgeons on how to properly monitor patients for potential problems.

The recall notice did indicate that problems linked to the Stryker V40 femoral heads could include the need for revision surgery, inflammation, damage to nearby tissue, dislocation, and fractures.

Even though a simple and inexpensive blood test can indicate whether or not a person has elevated levels of metals in the blood, the recall notice allegedly did not mention that surgeons should contact patients to perform the tests. Patients claim the recall notice also did not explain that the reason for the problems identified in the notice were due to extreme corrosion at the head and neck juncture.

“As a result, there are potentially several hundred thousand individuals with defective V40 heads whose hips are currently leaching toxic levels of cobalt and chromium into their bodies who are completely unaware that their hips are corroding,” says the Stryker V40 femoral head complaint.

The Stryker V40 Femoral Head Lawsuit is Case No. 2:17-cv-13733-GCS-MKM in the U.S. District Court for the Eastern District of Michigan, Southern Division.