The Free Press, Mankato, MN

Health & Fitness

May 12, 2013

Local cases part of hip device recall

MANKATO — A local attorney says his firm has about 30 cases in the nationwide recall of the popular Stryker Rejuvenate hip replacement device.

Jerry Maschka of the Maschka Riedy and Ries firm said they've been handling cases of people who have had problems with the device, including some who have already had their devices removed, and others who have yet to have them removed.

In either case, the devices are failing at an alarming rate. The Stryker Rejuvenate hip replacement has been implanted in nearly 20,000 people across the country. But problems with the device, according to the Food and Drug Administration, has led to thousands of court cases.

The device can be adjusted to accommodate the differing of various patients. But it appears the testing done, Maschka said, may have been inadequate.

“It's a modular implant that, in concept was good,” Maschka said. “But the testing may have been inadequate,” he said.

Users are reporting higher levels of cobalt-chromium – the material used in the device – in their blood streams. This may be the result of the metal-on-metal design, he said. Users are also reporting pain, and pockets of fluid.

“And as time passes,” Maschka said, “the failure rate of the implant seems to be going up.”

Right now the first of these cases is headed toward mediation. If those are successful, it could determine which direction the remaining cases go. If unsuccessful, they'll go to trial.

Maschka said Minnesota seems to have a disproportionate number of cases, although he wasn't sure why. He said it may be because of Minnesota's tradition of having a progressive medical culture, one that would have been an early adopter for something as innovative as the Stryker Rejuvenate.

Whatever happens, Stryker has a public relations nightmare on its hands. Because of that, they may want to dispose of cases quickly. Maschka said he estimates some cases – such as ones in which patients have already had their devices replaced – could resolve in as little as 16 months. Others, however, could last up to four years.

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