By the end of the year, the U.S. Food and Drug Administration (FDA) had stated it would make sure that high-risk medical devices were approved through the most stringent premarket approval (PMA) review process to assure the safety of consumers. But it looks as though that will not happen. High-risk […]

A new study reports on the likelihood of needing a second surgery after a hip replacement procedure for osteoarthritis, and the news is not good for men and younger seniors. Researchers from Brigham and Women’s Hospital in Boston analyzed data from 51,000 Medicare patients who received total hip replacements (THR) […]

Hip arthroplasty devices have been available in the U.S. for over 50 years with a variety of outcomes. An artificial hip medical device may be used to restore function of the joint, relieve pain or cure a disease or condition not responsive to a more conservative therapy. In May 2011, […]

This study comes from the Karolinska Institute in Sweden and was reported in the Journal of Bone and Joint Surgery in July 1991. Researchers studied nine uncemented hip prostheses that had been revised (removed). In four of the nine hips, researchers found tissue discoloration and corrosion at the head-neck junction.  […]

When participants left a two-day public hearing convened by the U.S. Food and Drug Administration (FDA) to discuss metal-on-metal hips (MoM) there were few answers and a lot of questions. The goal of the 18-member FDA advisory panel made up of surgeons, industry reps, and consumer advocates was to try and come […]

This is the typical refrain from so many of our clients who were implanted with defective metal-on-metal hip implants made by orthopedic giants like DePuy, Stryker, Wright Medical, and Zimmer. The irony is that those who utter those words are actually very close to the emerging stereotype for these clients. […]

The recent news about the Food & Drug Administration’s (FDA) actions in connection with hip implant manufacturers demands the question: why wasn’t the action being ordered required before the hip implants were placed on the market? The answer is that the FDA’s order to 20 device makers to study the […]

A jury in Oregon state court delivered a verdict of $5.5 million against I-Flow Corporation for causing devastating, permanent injuries to Matthew Beale by promoting the use of I-Flow pain pumps in joints. The pain pumps, like those used on Mr. Beale, were promoted by manufacturers including Breg, Stryker, McKinley […]

It is old hat in the medical device and drug industry; do not ask for permission—simply deal with the fall out of asking for forgiveness. The US Attorney’s Office announced indictments against a number of Stryker executives for lying to the Food & Drug Administration. Apparently, Stryker was given permission […]

Patients who undergo shoulder, knee and ankle surgery often experience significant pain; particularly immediately post surgery. To try and manage that pain, physicians have often employed the use of pain pumps. These pumps inject pain killer into the body in a regulated fashion to minimize pain, while controlling the tendency […]