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Though no official statement has been released, rumors have been swirling in the medical device industry over the status of Stryker Orthopedics Rejuvenate Modular Primary Hip System.
The Rejuvenate system was advertised as “The first hip replacement with over 100 ways to create a fit just for you” but concerns have arisen over its potential for deterioration (fretting) and corrosion within the body. This corrosion may be similar to the kind seen in metal on metal hip (MoM) implants, resulting in metallosis, a condition characterized by a build-up of heavy metals (specifically, cobalt and chromium) in the soft tissue around the hip and eventually flowing into the bloodstream. Elevated levels of chromium can cause DNA and chromosomal damage, while also negatively affecting various organs in the body. Cobalt exposure can cause cardiomyopathy and liver damage.
Though the Rejuvenate system is not a metal on metal implant, three necks and one stem of this product were recalled in Canada on May 28, 2012 over revision surgeries “associated with fretting and/or corrosion at or about the modular neck junction.” Metal on metal hip implants like the DePuy/Johnson and Johnson’s ASR XL Acetabular System, and the Zimmer Durom have received the most scrutiny from regulatory agencies, but the public needs to be aware that many types of hip replacements can cause serious illness and unexpected side-effects.
A new study released by three prominent orthopaedic surgeons states that modular implants like the Rejuvenate system are “associated with increased concern for component failure through taper fretting, fatigue fracture and local corrosion” which have the ability to cause metallosis and early revision.
Many people who have received hip implants in the past two years were promised a lasting implant that would remain working in the body for a longer period of time than other hip implants. This may not be the case with metal on metal hip implants and the Rejuvenate hip implant from Stryker. High rates of revision surgeries put patients at risk, and the toxicity of the main materials in the neck and stem of the Rejuvenate hip implant may cause more severe, systemic problems for many patients who have received in implant in 2010 through 2011.
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