Archive for March, 2010

Stryker Trident Plant is FDA Compliant

strykerStryker announced that it has been declared in compliance with FDA manufacturing standards and has satisfied issues raised in a 2007 warning letter over quality issues in its reconstructive implant factory that manufactured the Stryker Trident hip implant in New Jersey.

The warning in 2007 found that quality control failures contributed to problems with the implants, including the presence of staph infections causing bacteria and other quality control issues. The issues included reports of patients who continued to experience discomfort and pain after hip replacement surgery, improper wear of the hip implants and squeaking.

The company still has 2  outstanding warnings from FDA over manufacturing in Ireland or how the company sterilized its discontinued cranial implant kits.

Stryker is one of the world’s largest medical devices companies operating in the global orthopedic market.

Bisphosphonates Fracture Link Refuted

nejm

In the March 25 issue of the New England Journal of Medicine, new research suggests that widely used osteoporosis drugs called bisphosphonates do not boost women’s risk for femur or thigh fractures, which is something prior studies had suggested.

Bisphosphonates are the main class of drugs used to treat osteoporosis. Bisphosphonates include medications such as Boniva (ibandronate), Fosamax (alendronate) and Reclast (zoledronic acid).

The study was funded by was funded by the pharmaceutical companies Novartis and Merck, which both make bisphosphonates.

To read the full story, click here.

MMGs Detect and Avoid Nerves in Surgery

henry ford hospital

As more and more patients receive  minimally invasive surgical techniques it is more and more important to find effective methods for monitoring the location of nerves during surgery to avoid damage to them.

Now, a new a study by Henry Ford Hospital researchers suggest that Mechanomyography (MMG) can accurately detect and avoid nerves during surgery.

MMG systems measure the mechanical response of muscle following nerve stimulation, compared to traditional techniques that monitor the electrical response of muscles using electromyography (EMG).

For the full story, click here.

New Hip Replacement Treatment Uses Stem Cells

university of south hamptonScientists at the University of Southampton believe that they can use a patient’s own skeletal stem cells in the hip joint during bone grafting to encourage more successful regrowth and repair. This new discovery could replace the need for outside bone donors. The grafting technique referred to  is the one used to repair the thigh bone and joint during replacement (known as ‘revision’) hip replacement therapy.

In a two-year study, funded by the Medical Research Council (MRC), collaborative study between the University of Southampton and The University of Nottingham, researchers plan to test their theory by taking adult stem cells from bone marrow in combination with an impaction process and polymer scaffolds.

To read the full story, click here.