Sunday, November 18, 2012

Stryker Sales Slip Following Recall of Rejuvenate and ABGII Hip Implants

Stryker Orthopedics experienced a dip in its third-quarter sales, likely due to the recall of the Rejuvenate and ABGII in July of this year. While the sales of reconstructive joint implant systems dropped approximately one percent overall, Stryker’s hip implant sales dropped nearly 10 percent and its knee implant sales dropped 4.3 percent. Downplaying the seriousness of the recall on their financial bottom line, a company official stated that the recalls of the Rejuvenate and ABGII had only a “modest impact” on their overall revenues.

Economy as a Factor?

The recalls and the subsequent lawsuits may not be the only factors involved in the drop in hip implant sales. Joint replacement is generally considered elective surgery and the present economic climate many patients are putting joint replacement surgery on hold. Many of these potential hip implant recipients may not have health insurance, may have health insurance but can’t afford the out-of-pocket expenses, or simply can’t afford to take the time away from work when jobs are so scarce.

First Lawsuits Filed

According to the Stryker Hip Lawsuit Center the first Stryker lawsuit was filed in August of 2012, alleging the company designed, manufactured and sold the defective device without warning patients about potential risks and injuries. Seven more lawsuits have been filed since. It is likely these lawsuits will ensure the revenues of Stryker will drop in the fourth quarter as well.

CFO Steps Down

Stryker’s CFO & Vice-President, Curt Hartman reportedly received a $1.5 million dollar separation package –a combination of his annual salary of $750,000 plus his 2012 bonus. Hartman had been with the troubled company for two decades and will remain with Stryker through February of 2013 as an adviser—at his normal rate of pay. When Hartman leaves, he will be under non-competition and non-solicitation agreements.

Hip Implant Complications Led to Recalls

Unlike the metal-on-metal hip implants which have caused serious side effects in recipients, the Rejuvenate, which gained FDA approval in 2008, was believed to be a much safer alternative with its ceramic ball and plastic cup liner. There would be no metal ball and cup rubbing against one another leading to metal ion shear. Further, Stryker manufactured the stem and neck in two parts, allowing surgeons to choose the best size, according to their patient’s size and activity level. While it appeared the Rejuvenate and ABGII would offer greater performance and safety to implant recipients, in April of 2012 Stryker sent an Urgent Field Safety Notice to physicians and hospitals citing the potential risks of fretting—deterioration which can leave debris in the joint—corrosion, and the release of metal ions at the neck juncture.

Metal Trunnions Causing Problems

The Stryker Rejuvenate also contains metal “trunnions” at both ends of the neck piece allowing it to pop into the stem on one end and the ball on the other. Body fluids can become trapped in these trunnions, leading to further corrosion and the potential for the release of metal ions. The Rejuvenate and ABGII are subject to early failure as the components grind against one another, weakening the device and shedding metal particles just like the DePuy and Zimmer metal-on-metal implants. The metal shavings which shear away from the implant can either lodge in the surrounding hip tissue, causing infection and necrosis or enter the bloodstream, causing symptoms of metal toxicity.

The neck portion of the Stryker hip implant is manufactured of cobalt and chromium, just like the recalled all-metal hip implants. The Stryker stem is titanium coated. Despite the fact that the ball is ceramic, the Stryker Rejuvenate has a metal-on-metal intersection in addition to the trunnions which causes metal debris to shear away and enter the body. While the Stryker Rejuvenate may not release the level of metals into the body as the all-metal implants, there really is no safe level of metals. Patients who are extremely active have an even higher risk of having the metal parts rub against one another, leading to pain, necrosis and infection. It is likely that more lawsuits will follow as more implants fail or cause metal toxicity in recipients.

Author: Sullo & Sullo Attorneys

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