Smith & Nephew Modular Neck Recall
Patients who were implanted with the Smith & Nephew Modular SMF or the Modular REDAPT Revision Femoral Hip Systems should be aware of potential symptoms of hip replacement failure.
On November 15, 2016, Smith & Nephew sent out an urgent field safety notice to warn doctors and healthcare facilities that they were recalling these systems “due to a higher than anticipated complaint and adverse event trend.”
Potential symptoms of failure associated with these defective components include pain, difficulty walking, fracture, and hip implant failure requiring revision surgery. Some patients are already filing new Smith and Nephew hip implant lawsuits in an effort to recover damages.
What are Modular Necks?
Advanced technology has resulted in hip implant systems that are made up of a number of different parts. This way, surgeons can mix and match to create the best fit for any particular patient.
The neck component is the part that fits between the femoral stem (the part that goes into the thighbone), and the head (the part that goes into the hip socket). The problem is that both components are made of metal materials—namely, cobalt and chromium. Over time, these materials can rub against one another, shedding metal shards into the joint and the surrounding tissues.
These metals are poisonous to tissues, and can cause swelling, pain, inflammation, and non-cancerous pseudotumors. They can also enter the bloodstream, where they can cause metallosis. Metallosis is another word for metal poisoning, and can result in additional complications like nerve problems, cognitive impairment, heart problems, thyroid issues, organ failure, rashes, and even auditory and visual impairment.
What are Smith & Nephew Modular Neck Components?
The modular necks that Smith & Nephew is recalling are used in two of the company’s hip implant systems:
- Modular REDAPT Revision Femoral System
- Modular SMF
According to the company website, the REDAPT was designed to “allow the surgeon to address patients’ needs effectively and efficiently with many different hip stem options.” It allowed for fixation in various bone types, and provided the surgeon with the ability to customize the implant for the best fit without compromising strength.
The SMF system stands for “short modular femoral” hip, and was designed to be a “bone-sparing” implant, 20 percent shorter than other hip stems, that “conserves more of the patient’s femur [thighbone] than conventional stems.” Smith & Nephew assured physicians on its website that the implant would provide strength, stability, and versatility, with seven distinct neck positions to address patient anatomy.
Unfortunately, the neck and stem components in these systems were made with cobalt chrome alloy (CoCr), which allows metal-on-metal friction to occur.
Smith & Nephew Hip Implant Systems Increase Risk of Injuries
This isn’t the first time that Smith & Nephew has had to recall a metal-on-metal hip implant system because of problems with corrosion and metallosis. In 2012, they had to recall the R3 Acetabular system because the metal liner on the head part of the implant (which fits into the hip socket) was rubbing against the ball component.
In cases where both components were made of metal materials, the rubbing produced metal fragments into the joint and surrounding tissues. Over time, the resultant metal poisoning could cause loosening and eventual hip implant failure.
The R3 had a higher-than-normal revision rate of 6.3 percent in four years compared to the average of 2.89 percent for most implants. When these implants first reached the market, Smith & Nephew advertised them as being safer than the alternatives, but reports later showed that those claims were false.
Now, the Smith & Nephew modular necks and stems are causing the same types of problems. The company noted in their urgent field safety notice that they had observed a “rate of complaints higher than comparable monolithic hip prostheses.” They added that “metal-related 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.” They advised doctors that both of the hip implant systems would be removed from the market. They also recommended that doctors follow-up with their patients to monitor for symptoms like pain, swelling, and limited mobility. They also recommended they watch for high levels of metal ions in the blood.
The recall affects implants shipped from October 2008 to July 2016.
Types of Smith & Nephew Modular Neck Injuries
Patients who have been implanted with these modular necks are at a greater risk of revision surgery than those implanted with other comparable modular systems. Symptoms that may indicate the implant is loosening 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
Patients are advised to check with a doctor if they experience symptoms like these. 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
Revision surgery is typically more complicated and risky than the original hip implant surgery. Because of the metal poisoning, doctors usually have to clean and repair damaged tissues and bones. They have to remove the old hip implant, prepare the bone for the new one, perform bone grafting in areas of bone loss (if needed), and then implant the new hip replacement system.
If there is an infection, the revision surgery may have to be completed in two stages—the first to remove the old implant, after which the patient is treated with antibiotics for a period of time, and the second to implant the new prosthesis.
Revision surgery typically takes longer to perform, with a resulting longer recovery period. It’s one thing to have to undergo revision after 10-15 years of living with an implant, but having to do it after only a few years is disappointing, expensive, and can be extremely disrupting to patients’ lives.
Smith & Nephew Modular Neck Lawsuits
Patients who were implanted with the Smith & Nephew Modular SMF or the Modular REDAPT Revision Femoral Hip Systems may be eligible to file a Smith & Nephew modular neck lawsuit.
The company has already been defending many lawsuits over the past several years filed by patients who suffered complications from the R3 Acetabular system. It is expected that more lawsuits will now be filed concerning the Modular SMF and Modular REDAPT systems, especially as doctors and patients become more aware of the issues associated with these implants.
We provide consultations and case evaluations to help patients determine whether they may have a case against Smith & Nephew. Call today at 1-888-316-2311 or contact us.