SMF Hip System Redapt
Recalled Smith &Nephew SMF & REDAPT Implants
Searcy Denney is representing clients who have been implanted with the Short Modular Femoral Hip System and Modular REDAPT from Smith & Nephew in lawsuits alleging that the manufacturer failed to warn them of the risks associated with the device.
If you received a modular hip implant between 2008 and 2016 manufactured by Smith & Nephew, you could be at risk for serious side effects.
For decades hip implants often were manufactured in just a few sizes, with the stem and neck in one solid piece. These few sizes were intended for men and women, from 100 lbs to over 300 lbs, inserted into patients of a wide range of age, height, and varying anatomies as well as other conditions incurred from living a full life.
These single piece implants were successful, but comfort and range of motion could be restricted from the select sizes. Perhaps there could be room for improvement if a wider range of customization were available, allowing a surgeon to “tailor” an implant to more closely reproduce the patient’s native anatomy?
Dual Modular Hip Recalls Rooted in the 80s
In 1987, an Italian engineer patented the first “dual modular” femoral stems of the implant. The modular component means there were interchangeable neck and stems sizes which would improve sizing and length for the patient. The result would hopefully be a better outcome with less pain, improved comfort, greater mobility and durability hopefully lasting for the rest of the patient’s life. Unfortunately, European medical reviews were mixed.
A fundamental element of anything which may be two or more pieces is that they often meet at a “critical interface” where they are bound or “press-fit.” Such is the case with a dual modular hip; dual modularity refers to the femoral stem manufactured in two pieces instead of one, the other piece being the neck as pictured.
Critical interfaces will have what is known as “micro-movement.” It can be nearly immeasurable or slight vibration, however over time and tens of thousands of micro-movements, wear will begin to set in.
Modular Hips Begin to Come to Market
Despite the fact the Cremascoli design met mixed reviews in Europe, Wright Medical purchased the technology and in 2002 introduced its Profemur Z modular hip in the United States. It was the first dual modular femoral stem in the U.S. domestic market.
As with many consumer goods, if one manufacturer is making a type of product which may be more appealing, there is a rush to copy the product so as to not lose sales. Major medical device manufacturers, Zimmer, Stryker, Smith & Nephew, and others quickly developed their own modular systems, despite available medical literature stating Profemur Z was prone to failure, and other medical research showing fundamental issues with critical interfaces leading to corrosion.
Modular Hip Corrosion Becomes Metallosis
Unlike Wright Medical’s Profemur Z, and likely due to reported stem fractures, Stryker and Smith and Nephew
manufactured their modular necks out of chromium/cobalt where Wright Medical’s Profemur Z had used titanium. Chrome/cobalt alloys are much stronger than titanium, however, medical literature also showed that using mixed metals at critical interfaces could lead to failure.
Learn more about metallosis in this video presented by lead trial attorney, C. Calvin Warriner below:
Since the neck inserts into the stem and obtains fixation through a press-fit Morse taper junction, the mixed metals contact one another at a point of intense stress. Think of this has literally hammering one component into the other, in which the surgeon does use a large mallet to force the components together.
Unfortunately, micromotion between the two components is inevitable. With motion comes “fretting” or the gradual wearing and rubbing away of the metals. After a short period of use, this fretting, mixed with body fluids comes corrosion. When corrosion takes place, toxic metal wear byproducts are released into the surrounding tissue and bloodstream. This is the perfect environment for metallosis to begin. Metallosis results in severe pain, tumors of fluid, and necrosis or the death of body tissue surrounding the implant.
While all artificial hip implants carry health risks, the appalling part of this is that all of this information was well known and contained in the published medical literature.
Thousands of Recalled Hips Implanted; Painful Revisions are Likely
Thousands of patients were implanted with the Short Modular Femoral Hip and Modular REDAPT systems by Smith & Nephew, but the manufacturer is removing the products from the market because of a higher than normal incidence of adverse events. The most common negative side effects are bone loss, blood poisoning (metallosis), and revision surgery, causing pain and suffering to unsuspecting victims.
Searcy Denney devotes its practice to representing victims who have suffered at the hands of big corporations. We understand how difficult this time can be and we want to help make the process as simple as possible. Our skilled lawyers have the experience to answer all of your questions and can help you determine if legal action is right for you. If you are ready to speak with a lawyer, call us today at (800) 780-8607 for a no-obligation consultation.
To read our 2019 update on the litigation, click here to read our blog.
Serious Side Effects from the Smith & Nephew Recall
The main problems surrounding Smith & Nephew hip replacements are osteolysis and metallosis. Other complications may also be seriously injurious and even life-threatening.
Osteolysis is the weakening of bone tissue and bone loss surrounding the hip device. Symptoms of osteolysis include:
- Bone damage or bone loss
- Reduced range of motion
- Loosening sensation of hip replacement
Metallosis is blood poisoning that results from metal particle shredding that builds up in blood tissue. Symptoms of metallosis include:
- General hypersensitivity reaction (skin rash)
- Neurological and sensory changes (including auditory or visual impairments)
- Psychological status change (including depression or cognitive impairment)
- Renal function impairment
- Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)
Other complications experienced by patients implanted with the artificial hip devices include:
- Implant dislocation
- Debris wear
- Soft-tissue growth (pseudotumors)
- Blood clots
- Hip implant failure requiring revision surgery
Short Modular Femoral Hip System & Modular REDAPT System Recall Information
The Modular SMF and Modular REDAPT Hip System received fast-tracked approval through the FDA’s 510(k) process and were approved for sale in 2008 and 2012. Fast-tracked products are not typically required to submit “clinical data demonstrating safety and effectiveness” but instead may be approved if “substantially equivalent” to an existing product. (Congressional Research Service)
The 510(k) process removed the red tape of bringing a new product to market, however, reduced the process of testing, resulting in the American public becoming the test subjects based on what a manufacturer-defined as “substantially equivalent.” Unfortunately, with no oversight, corporations put profits over people.
Smith & Nephew’s Urgent Recall Notification
Smith & Nephew has faced a number of complaints and lawsuits that have led to mass recalls. In 2016, a class 2 recall was issued for the following modular necks used in two of the company’s implant systems:
- Modular REDAPT Revision Femoral System
- Modular Short Modular Femoral Hip System (SMF)
Implants affected by the recall include those from October 2008 through 2016.
On November 15, 2016, Smith & Nephew sent an Urgent Product Recall Notification letter to all distributing hospitals and physicians. Medical professionals were instructed to inspect their inventory and locate any unused devices to quarantine immediately. Doctors were advised that both hip implants would be removed from the market and instructed to monitor their patients for symptoms of pain, swelling, limited mobility, and high levels of metal ions in the blood.
How to Know If You Are Affected By a Recalled Hip Implant
Individuals receiving hip products were undergoing primary and revision surgery where other treatments and devices previously failed in rehabilitating hips. These implants are primarily used to fix prior hip replacements in patients with severely damaged hip joints as a result of trauma or degenerative disease.
Smith & Nephew’s Modular SMF and REDAPT Hip systems are indicated for uncemented use in individuals undergoing primary and revision hip surgery due to:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (NIDJD)
- Avascular necrosis
- Traumatic arthritis
- Slipped capital epiphysis
- Fused hip
- Fracture of the pelvis
If you are a hip implant recipient and think you may be affected but aren’t sure, call (800) 780-8607 today to speak with one of our defective medical device attorneys and learn if you qualify for compensation. If you are unsure what type of hip you may have we can help retrieve this information.
Who Is Responsible for My Injury?
The manufacturer of the medical device that injured you will be held liable—not your doctor.
UK-based medical technology company Smith & Nephew is a manufacturing company headquartered in London that manufactures joint replacement systems for hips, knees and shoulders for partial and total hip replacement, resurfacing and revision surgeries. According to the company’s annual report, hip implants brought in $597 million in 2016 alone while total worldwide sales were more than $4.6 billion.
Current Lawsuits Against Smith & Nephew
Lawsuits have been filed against Smith & Nephew alleging both devices have caused patients to suffer significant pain, often requiring additional surgery.
Lawsuits against Smith & Nephew fall into the category of defective products, which allege any of the following:
- Failure to warn: typically involves a product with inconspicuous dangers that requires special precautions while using it.
- Manufacturing defect: is a defectively manufactured product that is flawed because of an error that occurred during production.
- Design defect: involves a design that is inherently dangerous or defective.
This is not the first time Smith & Nephew has faced allegations.
In 2007, Smith & Nephew paid $28.9 million to the U.S. Department of Justice for illegally paying surgeons to use their implants on patients. As a result, the manufacturer was forced to undergo 18 months of federal monitoring.
June 2019 Update: Click here learn the latest on Smith & Nephew in our blog.
Contact the Defective Medical Device Attorneys at Searcy Denney
Hip replacement surgery is intended to improve quality of life—not cause additional problems. Your well-being should not be compromised by a dangerous medical device or its manufacturer’s questionable conduct. If you or a loved one suffered serious injury after being implanted with the Short Modular Femoral Hip System or Modular REDAPT Revision System, contacting an attorney should be your next step. Compensation could help pay for your medical bills, lost wages, pain and suffering.
Smith & Nephew promised groundbreaking advances in the hip replacement systems—but due to the company’s rush to put profits before people, many were injured. This should not have happened and Smith & Nephew should be held responsible for their negligence.
How We Can Help
The legal team at Searcy Denney Scarola Barnhart & Shipley has represented countless clients just like you, winning over $5.8 billion in verdicts and settlements. With over 40 years of experience as personal injury lawyers, our skilled attorneys have the resources and experience to build a successful case on your behalf. We understand how to protect your rights and will fight for the compensation you deserve. Contact us today at (800) 780-8607 for a free consultation to discuss your potential case.