Apex K2 Hip Implant Failure Lawyers
The Apex K2 is a modular, metal-on-metal hip which allows surgeons to customize the fit of the implant to suit a patient’s unique build and proportions. However, multiple studies have found a higher-than-normal rate of failure in recipients of the Apex K2 hip, and the device was even removed from the market in Australia in 2012 because of potential defects.
Our medical device attorneys are currently investigating Apex K2 hip implant lawsuits on behalf of injured patients across the United States.
Apex K2 Hip Overview
The Apex K2 hip implant is made by a Massachusetts-based company called OMNI Life Sciences and was approved through the FDA 501(k) process in 2004. The 501(k) is an expedited approval process which allows device manufacturers to forego human clinical trials if they are able to prove a device’s design is “substantially equivalent” to a device already on the market. Unfortunately, many of the previously approved metal-on-metal hips upon which approval of the Apex K2 was based have also proven to be defective or even been subject to recalls because of a high rate of failure and adverse events.
Problems with Apex K2 Hips
The following problems have been noted in recipients of Apex K2 metal-on-metal hips:
- Migration of Apex K2 hip stem
- Apex K2 revision surgery
One of the problems noted in recipients of Apex K2 hips is a condition called aseptic, lymphocyte-dominated vasculitis-associated lesions, or ALVAL. This can cause the growth of psuedotumors, chronic pain, inflammation, and other issues and often requires hip implant revision surgery.
In October 2012, approval of the Apex K2 hip was rescinded by Australian regulators and the device was removed from the market after research by the Australian Orthopaedic Association National Joint Replacement Registry showed an abnormally high rate of premature implant failure. According to this research, roughly 9.3% of all Apex K2 hip recipients required revision surgery to replace the device after only three years, and the average three year failure rate for artificial hips is 2.8%
In 2015, a two-year study published in the Journal of Arthroplasty observed “potentially concerning subsidence and retroversion in Apex K2 hips,” in addition to “significant and continuing migration…associated with increased risk of revision.” These researchers, led by Dr. Michael Kent of the Perth Orthopaedic Institute in Australia, noted high rates of metal poisoning, dislocation, infections, tissue damage, and other serious problems in recipients of Apex K2 hips.
Apex K2 Hip Lawsuits
While no Apex K2 hip recall has been issued in the United States at this time, a number of injured patients are now investigating Apex K2 hip lawsuits.
If you or someone you love has suffered serious, painful, and possibly debilitating problems after implantation with an Apex K2 hip, you could be entitled to substantial compensation for your suffering and damages. To learn more about your potential right to compensation, please contact our Apex K2 hip lawsuit attorneys today for a free and confidential evaluation of your claim.