Medical devices are big business in America. They are not quite as big a business in Europe and other countries, but manufacturers can still sell a $400 hip implant for several thousands of dollars. Joint replacements have increased significantly between 1997 and 2011. As we baby boomers continue to age […]
Search Results: stryker
Hurry up and wait appears to be the word from the U.S. Food and Drug Administration (FDA) when it comes to the safety of medical devices. The agency was supposed to have issued a final proposal by the end of June on a mandate to make it easier to identify […]
Many of our clients who have hip prosthesis wonder if they should have an image taken even though they are not experiencing any pain. A new study suggests that may not be a bad idea. Published in the May issue of The Journal of Bone and Joint Surgery, researchers find […]
The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]
In a 1993 published study, 148 retrieved modular hip prostheses of mixed titanium cobalt and chromium were examined to determine if they had corroded while implanted in humans. Significant corrosion was observed and it didn’t matter whether the hips were metal or a combination of metal and ceramic or other […]
Apparently, the FDA will expedite its abbreviated 510K approval process. The medical device industry is painting this as an improvement in the device approval process, but at what cost? And, for who is this expedited clearance process an improvement? According to an analysis from the medical device consulting company Emergo […]
A patient with a metal-on-metal or any hip replacement that causes symptoms or problems requires that the individual become his/her own best advocate. First, make an appointment with an orthopedic surgeon for evaluation which includes not just a physical exam but an examination of fluid around the joint/ soft tissue […]
In one of the largest studies of its kind, researchers have determined that women have a slightly elevated chance of needing a hip revision before a man. Researchers from Kaiser Permanente looked at 35,000 hip surgeries in 46 hospitals within their healthcare system. While men had an average of 1.9 […]
Stryker is finally acknowledging that their Rejuvenate and ABG II modular hip product line can cause serious problems in patients – even if they aren’t yet feeling symptoms of metal poisoning or tissue destruction. Since the Rejuvenate product recall on July 4th, Stryker has been telling patients that if you […]
This study published in the December issue of Arthritis Care & Research is the first to look at the risk factors that could lead to a revision after a primary total hip replacement (THR). In the U.S. population, identified by Medicare claims from 29 states, patients who were younger, taller […]