Birmingham Hip Lawsuits

Several models of the Smith Nephew Birmingham Resurfacing Hip (BHR) System have been recalled after the company admitted their device leads to a higher-than-normal rate of revision surgery. Smith & Nephew, a UK-based medical device manufacturer, has produced multiple hip resurfacing implant devices that have caused problems for recipients.

The company’s decision for a recall followed a high percentage of dangerous patient problems. Clinical results showed many patients with the BHR implant system needed revision surgery—the percentage was reportedly almost double the safety guideline set by Britain’s National Institute for Health and Clinical Excellence. Hip resurfacing is a newer surgical alternative to total hip replacement. Instead of replacing the entire femur with a prosthetic, a metal cap is fitted over the existing bone along with a matching metal socket. This allows patients to retain more of their original bone structure.

Patients have experienced symptoms including pseudo-tumors, chronic pain, and a local buildup of excessive metal particles. Serious complications may require revision surgery.

The failures of the defective medical devices have resulted in thousands of lawsuits, naming Smith & Nephew as the negligent party. The Lyon Firm is accepting implant cases involving hip replacement systems manufactured by Smith and Nephew, Wright Medical, Depuy, Stryker and Zimmer Biomet.

Joe Lyon is a highly rated product liability lawyer representing plaintiffs nationwide in a wide variety of medical device claims.  

Smith & Nephew Recall

In November 2016, Smith & Nephew, Inc. initiated a voluntary recall for the Tandem Bipolar Hip System due to a manufacturing error which affected thousands of their hip replacement devices.

The Smith & Nephew recalls affect implants that were manufactured out-of-specification and could potentially result in one of three functional failures: the device will not assemble, the head is too tight, or the device may appear to assemble but later disassociate post-operatively. Smith & Nephew issued a voluntary market removal of the modular neck, which is a common component in their Modular SMF and Modular REDAPT Revision Femoral Hip Systems.

Smith & Nephew recently reviewed product complaints and clinical study data associated with the modular hip prostheses, and noted a rate of complaints higher than comparable hip implants on the market. Metal-related Adverse Events accounted for the highest category of complaints in both products. The company says the implanted assembly could “potentially disassociate in the patient post-operatively, requiring a revision surgery.”

The adverse events reported to be associated with the Smith & Nephew hip implants were mostly related to high levels of metal in the joint area and in the blood of patients, and with the need for revision surgeries. Patients who have received REDAPT or SMF hips are at risk for developing the symptoms of a hip failure and should be monitored for pain, swelling, limited mobility, and other signs that a revision may be needed.

The company also recommends that patients be tested for levels of cobalt and chromium in the blood; metals from the hip replacements can cause dangerous reactions in soft tissue called metallosis.

Smith & Nephew BHR Implant Failure

Certain groups of patients are more likely to experience complications and require revision surgery after receiving a Birmingham Hip Resurfacing System implant. These groups include females, men aged 65 or older, and patients who require an implant head 48mm or smaller.

The symptoms of a failing hip replacement are potentially dangerous and must be attended to by medical professionals. Some of the warning signs include:

•    Severe joint pain
•    Bone fracture
•    Inability to walk
•    Implant dislocation or loosening
•    Dead tissue around the implant
•    Infection
•    Formation of cysts or pseudo-tumors
•    Allergic reaction to metallic debris
•    Cobalt or chromium poisoning
•    Nerve damage
•    Rashes

Birmingham Hip Resurfacing (BHR) & Metallosis

Thousands of recipients of the Smith & Nephew Birmingham Hip Replacement (BHR) System have reported severe complications and device failure. Perhaps the most serious complication is directly due to its metal-on-metal design.

The BHR components are primarily cobalt and chromium. When these metal components rub against one another, small cobalt and chromium particles are released into the bloodstream and accumulate in soft tissue.

Subsequently, there may be a toxic reaction to the metal debris called metallosis. Metallosis has been linked to chronic pain, dizziness, fatigue, and may lead to the dislocation of the implant, which requires revision surgery.

Metal-on-Metal Hip System Hazards

There are several known risks associated with metal-on-metal resurfacing hip implants. Patients have reported various problems soon after surgery or up to years after their initial implant. Chronic pain is common, as is the issue of metallosis. Some patients with metal-on-metal implants present with various symptoms and unusual tissue masses or pseudo-tumors.

The problems associated with the Smith & Nephew Birmingham Resurfacing Hip Implant and the R3 systems are similar to injuries caused by other metal-on-metal hip devices.

Metal-on-metal resurfacing hip implants were developed and marketed to be more effective than traditional hip implants, but a high rate of failure and potential need for revision surgery sheds a bleak light on the technology and Smith & Nephew’s hip replacement products.

Smith & Nephew Hip Recalls

In 2006, the U.S. Food and Drug Administration (FDA) approved Smith & Nephew’s Birmingham Hip Resurfacing System and R3 system for distribution.

The FDA initially approved the R3 to be used as part of the BHR system, and the two devices share a similar mechanism and rate of failure. Smith & Nephew first recalled the R3 in June, 2012 due to high failure rates, and the company withdrew the BHR system three years later under similar circumstances.

In June, 2015, Smith & Nephew announced the voluntary removal of some sizes of the BHR system from the market because of a greater risk of revision surgery than previously believed.

The company issued a field safety notice which warned consumers of the risks associated with their hip implant products. Patients have reported serious problems that include infection, fracture, dislocation, metallosis, and pseudo-tumors.

Smith & Nephew Hip Lawsuits

Many defective, untested devices are approved by the FDA each year because the agency does not require clinical trials for orthopedic implants if the device is deemed similar to an existing medical device already on the market. This results in many recalled products each year and many preventable injuries for American hip implant patients.

Attorneys and victims of failing medical devices are forcing companies like Smith & Nephew to take responsibility for the products they manufacture and distribute.

Any person who is experiencing a failing hip implant may have a claim against the device manufacturer. Patients who are experiencing pain, loss of mobility, inflammation, or instability should contact their implanting surgeon and an experienced attorney for legal assistance.

Smith & Nephew Birmingham Hips

Patients with a defective hip implant should follow up with a medical professional, particularly if they experience pain, loss of mobility, inflammation, or instability.

In the wake of this voluntary market removal of the Modular SMF and Modular REDAPT Revision Femoral Hip Systems, many patients who have suffered have already filed lawsuits against Smith & Nephew.

Victims and attorneys are filing Smith Nephew lawsuits and forcing medical device companies to take responsibility for the products they manufacture and put to market.

Metal-on-Metal Hip Implant Failure

Smith & Nephew is not the only artificial joint manufacturer to face legal problems. Other companies have designed and built artificial hip systems made of metal components that have turned out to be defective.

Medical experts say the problem comes from the fact that when the joint moves, one metal component rubs against another, causing small metal fragments to break away and enter surrounding tissue or blood.

Not every patient reacts poorly to the metal, but some patients experience painful, adverse local tissue reactions. This may lead to a loosening of the joint, pain, and ultimately the need for revision surgery.