While the OMNI hip replacement has not been recalled in the USA, this product has already come under scrutiny in some other countries. A medical device alert has already been issued by the Therapeutic Goods Administration in Australia, a regulatory agency responsible for managing the safety of therapeutic goods, similar what the FDA performs in America. It is very possible that this medical device will soon be on the radar in our country, as a report issued in Australia revealed that these hip replacement devices had a high revision rate – 9.3 percent failure after three years.
The K2, or Apex K2: Titanium Hip Replacement
While the K2 hip replacement is an advanced medical device, considered to be superior in that a surgeon can customize the implant for a better fit. Unfortunately, although this makes the K2 appealing for surgeons, the metal components may prove to be a problem. These devices are promoted by the manufacturer, OMNI, as being an excellent choice for younger, more active patients.
Metal-on-metal hip replacements have resulted in a range of dangerous adverse medical events from metal poisoning. The constant contact of the hip components may release tiny amounts of titanium or other metals into the body. This problem has become evident in the USA, where tens of thousands of patients have required hip revision surgery after getting implants from FDA-approved products from the top six hip replacement manufacturers: DuPuy, Biomet, Smith & Nephew, Wright, and Turner. Will hip replacement devices manufactured by OMNI Technologies prove to be a problem in the USA as well?
Medical Devices are recalled after they have had many reports of adverse events. For many people who have had either the OMNI K2 or the OMNI Apex K2, it may be only a matter of time until the number of adverse events reported leads to a recall.
Metal-on-Metal Hip Replacements: What Goes Wrong?
The concept behind hip replacement surgery is to restore mobility – and quality of life. The number of hip replacement surgeries performed in the USA is staggering – more than seven million people have already undergone the procedure. While a hip replacement that performs as it should can be a lifesaver for people who have lost range of motion or mobility due to a failing hip joint, when a medical device fails, it is a personal disaster.
The FDA reports that over time, metal particles around some brands of hip implants can cause tissue damage to the bone, tissue, or both. This is termed an “adverse local tissue reaction,” (ALTR) or “adverse reaction to metal debris” (ARMD). The medical problems associated with metal debris can include:
- Loosened implant
- Metallosis (allergic reaction to metal)
- Implant failure requiring replacement surgery
The K2 hip system was FDA-approved in 2004, and while the product has the unique customizable features, it is still a metal-on-metal implant and may pose a risk of releasing shards of titanium into the body, or as reported in Australia, have a high rate of breakage. The Apex K2 Femoral Stem is no longer approved in that country.
Meyers & Flowers: Chicago Trial Lawyers for Hip Implant Lawsuits
At Meyers & Flowers, our team of seasoned trial lawyers pursues justice and full compensation for those who have suffered serious injury after undergoing hip replacement surgery. Our extensive experience in complex medical device trials allows us to level the playing field for our clients. Companies manufacturing these devices have teams of defense lawyers who work hard to attempt to limit financial losses. It is necessary to have an equally-powerful team on your side when seeking compensation for financial losses as well as pain and suffering.
If your hip implant was manufactured by OMNI Technologies, and you are now experiencing any of the symptoms of metallosis, failure, pain, or other symptom, or have been advised that your implant has failed and must be replaced, we urge you to contact our firm to discuss your legal rights and what may be possible in a case filed against the manufacturer. We have access to a wide range of medical experts who can assist in evaluating your case, including performing tests to discover the underlying cause of the failure, pain, or other symptom.
What is Metallosis?
Metallosis is the medical term for blood poisoning from exposure to toxic metals. The symptoms of an allergic reaction to the tiny pieces of metal debris released by a faulty hip implant, according to medical research, may include:
- esearch, may include:
- Heart problems
- Vision impairment
- Cognitive impairment
- Hearing loss
- Clicking or popping at joint
Metal-on-metal implants are a common choice for surgeons performing hip replacements, as these medical devices are considered to be more durable, have a more natural fit, and can be customized to suit the patient. Unfortunately, as the years pass, more of these medical devices have been recalled due to adverse health events. Once a serious health condition associated with a hip implant is identified, the only option for the patient is to undergo hip revision surgery.
Any surgical procedure carries some risk, and these risks are higher for the elderly. Hip revision surgery is more extensive than the original hip replacement procedure. The incisions are larger, and subsequently the risks may be higher. Many patients will require bone reconstruction as part of the surgical procedure.
Testing for Hip Implant Failure
Various tests will be used to attempt to identify the problem when a hip implant fails. These diagnostic tests can include:
- Blood testing to identify the presence of infection
- Extraction of fluid around joint for evaluation
- Imaging tests, such as MRI
We Are Here to Help.
Our team of dedicated Chicago trial lawyers is here to protect the rights of people who have suffered serious injury from a faulty or defective medical device, including metal-on-metal hip implants. We have spent our entire professional careers seeking justice in these cases and have a stellar reputation for our legal work. We urge you to contact us or fill out our free online case evaluation to get the answers you need about moving forward with legal action.