Sales Dip for Stryker Following Hip Implant Recalls

Stryker sales have shown a definite dip in the quart since the recall of the Stryker Rejuvenate and ABGII hip implants in July. The hip implant recall came just months after Stryker issued an Urgent Field Safety Notice to hospitals and physicians in April of 2012 citing the potential of fretting and corrosion at the neck juncture as well as the risk of metal ion release. Stryker’s hip implant sales dropped nearly 10 percent while its knee implant sales dropped 4.3 percent.

Why the Dip in Revenues?

A Stryker company official stated the recalls of the Rejuvenate and ABGII had only a “modest impact” on the company’s third quarter drop in sales. While the recalls certainly would have impacted Stryker’s revenues, the overall economy may also have played a part. Joint replacement surgical procedures are considered elective most of the time. Those with insurance may delay the surgery to avoid missing work while those without insurance likely cannot afford the procedure. Stryker’s CFO, Curt Hartman also stepped down after two decades at the helm. He reportedly received a 1.5 million dollar separation package although he will remain as an adviser to Stryker through February, 2013.

New Design an Improvement Over Metal-on-Metal Implants?

Metal-on-metal hip implants have been responsible for scores of side effects among recipients. The Rejuvenate garnered FDA approval in 2008 and the ABGII in 2009 and were believed to be not only safer than the all-metal implants but the design was innovative in that the stem and neck were separate parts and were manufactured in a variety of sizes. The surgeon could choose the best size according to the size and activity level of the patient. Because the ball of the Stryker models was ceramic and plastic lined the acetabular cup, it was assumed there would be no metal-on-metal parts rubbing against one another, resulting in metal ions shearing away into the body.

Risk of Metal Ion Release

Unfortunately, the neck portion of the Stryker Rejuvenate is made of cobalt and chromium and even though the ball is ceramic, there is a metal intersection as well as metal trundles at both ends of the neck portion. Body fluids trapped in the trundles can lead to corrosion and the metal intersections can also corrode, sending metal ions into the surrounding tissues or the bloodstream. Although the levels of metal ions in the bloodstream from the Rejuvenate may not reach the level of the all-metal implants, any metal in the body can cause issues for the patient. Those patients who are extremely active have an even greater risk of metallosis, leading to pain, necrosis, infection and failure of the implant. While Stryker’s sales may have taken a dip, it is likely that they will soon have bigger problems as eight lawsuits have already been filed following the Rejuvenate and ABGII hip implant recalls. 

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