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 hip implant between 2008 and 2016 manufactured by Smith & Nephew, you could be at risk for serious side effects.

Thousands of patients were implanted with the Short Modular Femoral Hip and Modular REDAPT systems, 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, and revision surgery, causing pain and suffering to unsuspecting victims.

If you are experiencing painful side effects as a result of your Smith & Nephew hip system, you are not alone.

This article provides information on how this recall may affect certain Smith & Nephew hip implant recipients.

• The Problem Behind the SMF Hip System & REDAPT
• Serious Side Effects
• Short Modular Femoral Hip System & Modular REDAPT System Recall Information
• How to Know If You Are Affected
• What to Do If You’ve Been Injured by Your Implant
• Who Is Responsible for My Injury?
• Current Lawsuits Against Smith & Nephew
• Have You Suffered as a Result of Your Hip Replacement?

The Problem Behind the SMF Hip System & REDAPT

All artificial hip implants carry risks.

However, metal on metal implants have unique risks. The problem lies in the metal material the artificial hips are made from, cobalt and chromium. These materials rub against each other, sometimes shredding metal shards into joints, tissues and eventually into the bloodstream. This is known as metallosis, a form of blood poisoning.

Over time, metal particles can cause damage to the bone and tissue surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure, and the need for revision surgery.

Serious Side Effects

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:

• Inflammation
• Pain
• Infection
• 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)
• Cardiomyopathy
• 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
• Infection
• Fracture
• 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.” (Congressional Research Service)

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

Individuals receiving the 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)
• Osteoarthritis
• Avascular necrosis
• Traumatic arthritis
• Slipped capital epiphysis
• Fused hip
• Fracture of the pelvis

These hip implant systems are made of a number of different parts, allowing surgeons to mix and match to create the best fit for the patient. The devices have an interchangeable part between the femoral stem and femoral head designed to interlock with a liner and metal component. This creates a “metal on metal” design.

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 based 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.

Have You Suffered as a Result of Your Hip Replacement?

While hip replacement surgery is life-changing for many living with crippling joint pain, others have not been so fortunate.

Defective hip products that were irresponsibly marketed and undertested have caused countless victims to suffer pain, injuries and undergo additional surgeries.

Hip replacement surgery is a common practice in the United States. According to a study from American Academy of Orthopedic Surgeons, .8 percent of the population has an artificial hip.

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.