Omni Apex K2 Hip Implant Failure Attorneys and Lawsuits
The OMNI Apex K2 Hip Replacement System is one of numerous metal-on-metal hip replacement products on the market that have an abnormal failure rate and risk of complications which require surgical intervention to address.
The hip replacement defect attorneys of Rosenfeld Injury Lawyers LLC are currently investigating claims by patients whose injuries were the result of failures and product flaws associated with these devices. If your hip Apex K2 replacement failed prematurely or you suffered from internal tissue damage, bone fractures, device breakage or conditions such as metal poisoning (metalosis), you may be entitled to receive compensation for the cost of your medical treatment, pain, and suffering and out of pocket expenses.
Uses for the OMNI Apex K2 Hip Replacement SystemThe Apex K2 Modular Hip System is produced by OMNI and the device first received clearance from the FDA for sale in 2004. It has a variety of uses that include the correction of deformities present at birth, the replacement of a hip damaged by rheumatoid arthritis, the treatment of osteoarthritis and the replacement of fractured hips that cannot heal properly by conventional means. The success of this system is due to its adaptability— each implant can be custom fitted to each patient through an adjustable stem, neck, and head.
According to FDA data, there are a total of 96 configurations for the hip system for the neck and head, making it easy for surgeons to fit or adjust the device when determining the proper fit. The stem is placed inside of the thigh bone and connected to the neck through a small metal neck. The ball joints can be made of ceramic or metal, and the metal on metal configurations cause the most problems due to the grinding of metal parts and the production of metal shavings inside of the body.
Common Complications Associated With Metal on Metal Hip Replacements
The OMNI Apex K2 Hip Replacement System isn’t the only hip implant that has been scrutinized over early failure and complications arising from its metal on metal components (see Stryker and DePuy hip pages for more information). Like other systems, the metal components can lead to the early erosion of the device, injuries to the joint and a heavy metal poisoning called metalosis— which occurs due to elevated amounts of heavy metals such as chromium and cobalt in the bloodstream. The following symptoms may indicate that you require revision surgery or to have the medical device removed.
- The development of infections within the joint. This may be accompanied by the formation of scar tissue caused by the accumulation of metal shavings within the hip.
- Audible sounds coming from within the implant. Patients will often hear popping or grinding sounds that can be distracting and embarrassing.
- Extreme pain and discomfort due to inflammation of the joint and surrounding tissue. This is most commonly due to metal shavings working their way into the body from the grinding of metal parts against each other.
- Sudden changes in vision or hearing, including the complete loss of auditory or visual function.
- The onset of cardiomyopathy and other heart conditions, which can ultimately lead to heart failure.
- The loss of cognitive function such as the ability to recall events, concentrate or communicate with others.
- Previously undiagnosed thyroid problems caused by the impact that base metals have on the lymphatic system.
- The hip implant breaks at the neck. This failure requires immediate medical attention and there is no treatment option other than to operate on the device. The break may also fracture the femur, making it even more difficult for surgeons to repair or replace the device.
Australia Removes Omni K2 Device From MarketIn a move to protect patients, the Australian Register of Therapeutic Goods pulled the Apex K2 Hip Replacement System from the market, citing a failure rate of almost one in ten devices. In addition to concerns over the implant system’s failure rates, another study was cited revealing a link between metal on metal implants and a tissue disease called aseptic lymphocyte-dominated vasculitis-associated lesions. Patients with this condition develop benign tumors in the joint and the surrounding areas become inflamed and produce a milk-like discharge.
The Apex K2 Hip Replacement System was removed from the Australian market in 2012 and the United States should have quickly followed suit. While competitors have taken proactive measures such as recalling devices and components which have been proven to be harmful, OMNI has taken no such action and continues to market these devices.
Medical Device Recall Attorneys Committed to Your Success
Contact us today to arrange a free and confidential consultation with one of our highly experienced hip implant injury attorneys. We will be happy to come to you as well if it would be more convenient. As all our lawyers operate on a contingency basis, you are assured that you will never be required to pay an upfront fee to retain our services and if we fail to secure compensation on your behalf, our services will be free of charge.