OMNIlife hip replacement implants have been shown to have a high rate of failure and side-effects
Hip replacements aren’t just for older adults.
The majority of hip replacements are in patients between 60 and 80 years old, but younger people can suffer hip problems for which replacement is an option, too. Some hip replacements are performed in teens or young adults.
But, like any medical procedure, there are risks and benefits. One of the risks is an OMNIlife hip implant. Specifically, lawsuits are pending related to patient injuries from the OMNIlife Science Apex K2 Modular Hip System hip implant.
These implants are alleged to have a high failure rate because of corrosion and fretting complications and could include loosening, subsidence, migration or a combination of these issues. As a result, a patient could suffer from a fracture or metallosis.
What is an OMNIlife hip replacement implant?
OMNIlifescience, Inc. acquired Apex Surgical medical device manufacturer in 2004. The Massachusetts-based manufacturer now produces the OMNI Apex K2 hip replacement, which went on the market in 2004. The product was FDA-approved that year, but the program that approved this device does not require human clinical trials if the manufacturer demonstrates that the new product is substantially equivalent to a different product that was previously FDA-approved under normal standards.
The OMNI Apex K2 hip replacement includes a femoral stem and a modular neck and head that can adapt to fit each patient correctly. The neck and stem are constructed of titanium alloy and the modular connection has a cobalt-chromium anti-rotation peg. This combination can be adapted in 96 configurations to fit even a patient with unique anatomy.
OMNIlife hip implant failures
The Journal of Arthroplasty published a 2015 study that found that the OMNIlife Apex K2 hip implant has an above-average rate of failure and complications. Some fail in as little as a year following implantation.
The researcher followed 95 patients who had received Apex K hip stems. Of them, 17 had complications that included dislocation, blood clots, infections and reactions to metal particles. This is because of breakdown and corrosion of the neck and stem, which could have allowed microscopic metal particles to enter the bloodstream.
These patients reported pain and were diagnosed with tissue reactions to higher levels of cobalt and chromium in the blood and tissues.
Some of the patients experienced aseptic, lymphocyte-dominated vasculitis-associated lesions (ALVAL), which can cause pseudotumors, or discharge and swelling around the implant site. Two of the patients required surgery to remove infected, diseased tissue and to remove the implants.
Symptoms of a failed hip replacement
How do you know if there are problems with your hip replacement? After all, you can’t see it. You can’t really feel the implant, itself. What are the symptoms that tell you that perhaps you’re dealing with a hip replacement failure?
There are several defects that could cause painful and dangerous symptoms. These include loosening or breakage of the implant. It could also be that the metal-on-metal components rub together and cause metallosis, which is when the tiny pieces of metal break off and enter your bloodstream.
The only way to treat a hip replacement failure is to have the implant surgically removed. But even then, the effects from metallosis can be long-lasting and not easily treated.
Dede’s Story: A tragic accident leads to a hip replacement and metallosis
Dede Kolb was 35 years old and had everything to look forward to when she was the victim of a tragic accident caused by a drunk driver.
One of the treatments Dede received after the accident was a hip replacement. Several years later, she began to experience symptoms like brain fog, forgetfulness, and cognitive difficulties. She began to worry about the possibility of a neurological issue or early-onset Alzheimers Disease.
But then she discovered that her defective hip implant had caused metallosis. The metals had damaged her brain’s frontal lobe, which controls executive function. She had a high level of cobalt in her blood. More than 20 years later, Dede still suffers from cobalt poisoning.
Her symptoms include depression, impaired executive function, trouble completing tasks, brain fog, difficulty finding words, chronic fatigue, chronic frontal headaches, metallic taste and memory deficits. This has affected her ability to work, her relationships with her family, and nearly every aspect of her life.
You can read the full story about Dede’s accident, recovery, and the road ahead: https://www.enjuris.com/blog/my-accident/dedes-story/
Costs of a hip replacement revision
There are several costs that a patient incurs when they have a second hip replacement, or a hip replacement revision, within a short time after the first. These include:
- The risks of an additional surgery (every surgical procedure has risk, some are riskier than others)
- Loss of income during time out of work
- Lengthy hospital stays and frequent doctor visits
- In-home, inpatient or outpatient in-facility rehabilitation
- Extended home care
- Prescription drugs and risks associated with certain painkillers
- Costs of home renovations to accomodate a disability
OMNIlife hip replacement lawsuits
There are more than 29,000 lawsuits that have been filed against hip replacement manufacturers; these are not just against OMNI, but also Stryker, DePuy, Zimmer and Biomet. More than $7 billion has already been paid out in settlements and verdicts, and there will likely be more to come.
More than 30 OMNIife hip replacement devices have been recalled by the FDA since 2009.
Compensation for an OMNIlife Apex hip replacement patient
If you’ve received a defective medical device like a hip replacement, you could be entitled to compensation if the device caused you harm or illness.
However, these are complex legal cases and it’s important that you consult a skilled personal injury lawyer who’s experienced in pharmaceutical device defect lawsuits.
In order to recover compensation in an OMNIlife lawsuit (or one against another pharmaceutical company), the plaintiff (injured person) must prove that the device was defective and that the defect caused their secondary injury or illness. In other words, they need to be able to show that the symptoms related to the defect were, in fact, caused by the defect and not by some other reason.
If you were injured or became ill from a defective OMNIlife Apex hip replacement implant, you could receive compensation to cover costs that include:
- Medical treatment, including subsequent surgeries, hospital stays, doctor visits, prescription medication, etc.
- Rehabilitative therapies
- Prosthetics and assistive devices (like wheelchairs, walkers, etc.)
- Lost wages
- Home modifications (wheelchair ramps, door widening)
- Pain and suffering and mental anguish
- Other expenses for transportation, assistance with activities of daily life, and costs related to the injury
What to do if you think you’ve suffered injury from an OMNIlife Apex hip replacement
The first priority is always your health and safety. If you’re suffering from any ailment or feel pain, you should seek the advice of a trusted medical professional.
If your doctor diagnoses you with something that could be linked to metallosis or other known issues with the implant, you should contact a personal injury lawyer.
It’s also important to keep detailed notes and records of your experiences. You can use resources like this daily pain journal, medication log sheet, or your own methods for recordkeeping.
You should keep a record of the date and how you feel each day; no symptom is too small. The reason for this is that if you ever go to trial, your testimony will be much more compelling if it’s detailed. In other words, instead of saying, “After my hip replacement, I had a lot of headaches,” you could say, “Beginning on October 12th, I had a headache on the 13th, 14th, 16th... [etc.] and I needed to take [this medication] on a regular schedule in order to get relief.”
It’s much harder for the defense to argue against specific records than generalizations and relying on memory.
- Hip Replacement Surgery
- DePuy Orthopaedics Hip Replacement Devices
- Hip Replacement Complications
- Hip Replacement Lawsuits
- Hip Replacement Surgery Overview
- Metallosis from Hip Replacement Devices
- OMNIlife Hip Replacement Lawsuits
- Recalls for Hip Replacement Devices
- Smith & Nephew Hip Replacement Devices
- Stryker Orthopedics Hip Replacement Recalls and Lawsuits
- Wright Medical Hip Replacement Devices
- Zimmer Biomet Hip Replacement Recalls and Lawsuits