Smith & Nephew Modular Neck Recall
Hip replacement surgery is a complicated procedure that requires significant recovery time for the patient. Patients going through it hope to have their pain relieved and their mobility returned.
Those in the Pittsburgh and surrounding Ohio Valley areas who were implanted with the Smith & Nephew Modular SMF or Modular REDAPT Revision Femoral Hip Systems, however, should be aware of potential complications. The company recently sent out an urgent field safety notice warning orthopedic surgeons that these implants can create problems like metal poisoning, pain, inflammation, and hip implant loosening. These complications can result in hip implant failure.
Because of a higher-than-expected rate of problems, Smith & Nephew is recalling both of these systems, and withdrawing them completely from the market. Doctors have been told to locate and quarantine any unused devices immediately and return them to the company, and to follow-up with patients and monitor for pain, swelling, limited mobility, and pockets of swelling.
What Went Wrong with the Smith & Nephew Modular Hip Implants?
The problem is that two of the components in this system—the modular head and the modular neck—are both made of metal materials, namely, cobalt and chromium. Over time, these materials can wear against one another, shedding tiny metal fragments into the surrounding joint and tissues.
These metal fragments are poisonous to tissues, and can cause inflammation, swelling, pseudotumors (non-cancerous, fluid-filled tumors), bone damage and bone loss, and gradual loosening of the implant that can lead to failure.
Some of these fragments can also enter the bloodstream, causing a condition called “metallosis.” This is also dangerous, as it can lead to tissue neurosis, metal poisoning, nerve damage, and organ damage.
This is the same problem that’s occurred with several other hip implant systems, including the Smith & Nephew R3 Acetabular system. Back in 2012, the company recalled this system, too, because the metal components were rubbing together and causing corrosion and metallosis. In this case, it was the metal liner on the head component (the part that fits into the hip socket), and the ball component, which fits inside the metal liner.
After it had been on the market for a few years, the R3 was linked to a higher-than-normal revision rate of 6.3 percent in four years compared to the average of 2.89 percent for most implants.
Now, the Smith & Nephew Modular implants are showing a similar trend of being linked with a higher rate of problems than was expected. In their field notice, the company stated that the complaints were “trending upward,” with an overall complaint rate (number of complaints compared with total implantations) of 0.527 percent for the Modular SMF and 0.25 percent for the Modular REDAPT system.
“Overall,” they stated, “the Metal-related Adverse Events accounted for the highest category of complaints in both products.”
Modular Hip Implants Increase Risk of Corrosion and Loosening
A modular neck hip implant is a hip implant system designed to have an interchangeable femoral neck. This is the part of the implant that serves as a bridge between the femoral stem that goes into the thighbone and the head, which goes into the hip socket.
With modular systems, surgeons can choose which neck will provide the best fit for each patient. Smith & Nephew offered several options, so that doctors could build the implant to not only work well with the anatomy of the patient, but also to provide the best movement angle and mobility.
In a 2009 study, researchers acknowledged that modular neck implants “are an attractive treatment tool in total hip replacement.” The ability to adjust the center of the head relative to the stem, by connecting the neck in a different position was thought to provide versatility during surgery.
They also noted, however, that “fretting caused by micro-motion between the modular components may lead to particle and ion release to the surrounding tissue.” These metal particles can become trapped between the surfaces, leading to bone loss, corrosion and implant failure.
A 2009 study review on modular neck hip systems reported that since the early 1990s, there has been a dramatic increase in total hip implants with modular necks. Again, the researchers acknowledged the clinical advantages of the modular neck, as it allows surgeons to properly fit leg length and angle. In reviewing 16 studies, though, they found that six of the neck components showed significant fretting, as well as corrosion in the neck-stem taper after only about 39 months.
Researchers concluded that even with corrosion-resistant materials, “increased modularity can lead to fretting and crevice corrosion, metal ion generation, and particulate debris that may contribute to” bone loss and hip implant loosening.
Unfortunately, Smith & Nephew Modular Hip implants, as well as other brands of modular implants made of metal materials are having these issues.
Types of Smith & Nephew Modular Neck Injuries
Patients in the Ohio Valley area who have been implanted with Smith & Nephew modular hip replacement systems need to be aware of potential complications. Early symptoms of corrosion, fretting, or metallosis include:
- Swelling in the area of the implant
- Difficulty walking or getting up from a seated position
- Noise coming from the implant, like clicking or popping
A thorough examination can reveal if there are problems with the implant. Doctors can perform blood tests to check for metal ions in the bloodstream, and can use imaging tests to look for signs of swelling, inflammation, pseudotumors, or indications of implant loosening.
If the components are rubbing against one another and causing friction and shedding, complications may include:
- Loosening hip implant
- Metal poisoning (metallosis)
- Soft-tissue growths (called pseudotumors)
- Bone damage and bone loss
- Confusion, headaches and dizziness
- Tingling in the arms and legs
- Hip implant failure requiring revision surgery
Risks of Smith & Nephew Revision Surgery
Patients who develop these symptoms because of metal fretting are likely to feel very disappointed. Hip implant systems are supposed to last from 10-15 years. Patients that end up with problems like these usually start to fail within a much shorter time, often 2-4 years.
Doctors can fix the problem by performing revision surgery, during which they remove the problematic implant and replace it with a new implant. Unfortunately, these surgeries are typically more complicated and come with more risks than initial hip implant surgeries. They take longer because the surgeon has to clean out any corrosion and address any damaged or dead tissue around the joint. They have to remove the old implant, which can take time because usually there has been some bone growth into the implant itself.
Once they have removed the old one, they then implant the new one, but recovery often takes longer for the patient than following the initial surgery. That equals more lost wages, and more financial pressure on families, say nothing of the personal pain and suffering.
All of this creates a huge upset in a person’s life, which is why patients diagnosed with premature hip implant failure should check with a Smith & Nephew hip implant lawyer. Manufacturers should be held responsible for failing to properly test and study their products before releasing them on the market, and injured patients deserve compensation for medical costs and other losses.
Smith & Nephew Modular Neck Lawsuits
If you or a loved one were implanted with a Smith & Nephew Modular SMF or Modular REDAPT hip implant system and then suffered from complications, you may be entitled to compensation. Patients shouldn’t have to shoulder the costs for revision surgery, recovery care, lost wages, and more on their own.
Call today for a free and confidential case evaluation at 1-888-316-2311. Our Pittsburgh law firm represents individuals in West Virginia, Western Pennsylvania, and Eastern Ohio.