Friday, September 21, 2012

The Problems with Stryker Metal-on-Metal Hip Replacement System


Orthopedic disease and trauma affect millions of people each year, media reports say. They potentially limit mobility, decrease productivity and reduce the quality of life. There are patients around the world who have come to depend on hip replacement products in hope that it may help them by restoring normal function, reducing pain and returning their normal daily activities. Stryker Orthopaedics is a global leader in the development, manufacture and sale of orthopaedic products and services such as the hip replacement systems. However, their orthopaedic products are associated with problems which led to recall. The implant systems Rejuvenate and the ABG II are voluntarily recalled by Stryker.



Stryker’s decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate its global distribution of these products comes after continued post-market surveillance. Because these two hip replacements are made of metals, it could potentially generate metal debris as the joints wear. It has been thought that metal debris is incompatible with the human tissues.


Metallosis, also known as metal poisoning, occurs when metallic debris is released into the body’s bloodstream. Usually, the condition refers to cobalt and chromium particles that are absorbed into tissue as a result of faulty metal hip implants. High levels of metal particles may potentially cause organ damage. Small metal debris is produced by the grinding of the two metal surfaces (ball and socket). As a result, the immune system identifies the metal ions as foreign objects and aggressively attacks the soft tissues containing them. Damaged and inflamed tissue can contribute to premature loosening of the hip implant. Metallosis may also lead to necrosis which is characterized by extreme skin rash and death of skin cells.


The Food and Drug Administration (FDA) has received over 16,800 reports of problems with metal-on-metal hip replacement systems from 2000 to 2010. Fourteen thousand patients had to undergo revision surgery to remove the defective implant and replace it with a new one. However, government health experts said that there are a few reasons to continue using the metal hip replacements, amid the growing evidences that the device may prematurely break down and expose patients to dangerous metallic particles.


People who received the Rejuvenate and ABG II implants may potentially suffer severe injuries. For this reason, they may need to consult a doctor or simply refer to the Stryker Hip Recall to know the potential complications.



References:



drugwatch.com/hip-replacement/

nytimes.com/2011/08/23/business/complaints-soar-on-hip-implants-as-dangers-are-studied.html?pagewanted=all&_moc.semityn

rsc.org/chemistryworld/2012/07/why-some-metal-hip-replacements-fail

usatoday.com/news/health/story/2012-06-25/metal-hip-implant-risks/55845858/1