For the past two years, Dr. Robert Zann said he implanted the Stryker Rejuvenate and ABGII modular hip systems to repair 400 joints, said The Palm Beach Post. In the past year, Zann has removed 100 of the defective systems and expects to remove another 100 devices.
Zann said he is seeing blood contamination and fluid-filled, painful masses in the area of the joint device in his patients. He believes that the Stryker Rejuvenate and ABGII hip prosthesis recall will be remembered among the most serious medical device failures in recent years. In fact, said The Palm Beach Post, the revision rate could reach or exceed 50 percent since its approval in 2009.
“When I start operating it is the same mess in them, every single one,” Zann said, describing a “high-pressure fibrous tumor-like pocket” that is full of fluid to the point in which the mass “pops” when cut. Zann also described inflamed muscle, and white, milky fluid surrounding the joint, The Palm Beach Post said.
Revision surgery to explant or remove a defective device is a complex, painful, and costly procedure. Zann said the operation wears on the surgeon, as well. “We are exhausted right now. This is wearing us down. This is really wearing us down,” Zann told The Palm Beach Post. A revised device may perform worse than the original, removed device, say surgeons, due to issues involving bone loss.
We recently wrote that Stryker was asked to cover Rejuvenate him implant monitoring costs for Florida patients following a request made in a purported federal class-action lawsuit filed over the Rejuvenate device. Stryker recalled its Rejuvenate implants in July 2012 and, earlier this year, advised patients implanted with the Rejuvenate to speak to their surgeons about checking the implant for problems, according to court documents, said MassDevice previously. The documents also cite a “risk of fretting and corrosion at the modular neck junction.”
Zann said that he is removing a recalled Stryker system one time per every five surgeries he performs and his office has been overrun with patients implanted with the Stryker devices who have responded to his warning letters asking them to come in for an MRI and metal testing, said The Palm Beach Post. “This has been the worst year of my life,” Zann said. “I’m so frustrated I can’t tell you.”
More than 80 lawsuits have been filed in New Jersey’s Bergen County, alone, which is where Stryker is based, said The Palm Beach Post. Another 30 have been filed in federal court and more are expected.