Smith & Nephew Birmingham Hip Resurfacing System Recalled

What should I watch out for?

Deterioration of the hip is painful and usually includes difficulty walking, stiffness, and general loss of mobility. If physical therapy and other conservative treatments fail, total hip replacement surgery or hip resurfacing surgery may be necessary.

Approximately half a million people undergo hip replacement surgery each year. Problems exist on many of the hip implants, resulting in investigating by the U.S. Food and Drug Administration (“FDA”) and device recalls.

The Smith & Nephew Birmingham hip resurfacing system is one recalled hip device. This device has severe complications and can cause dangerous amounts of metal into patients’ bloodstreams.

What side effects do artificial hip implants cause?

All surgery carries inherent risks, including hip replacement surgery. Risks associates with surgery in general includes excessive bleeding, blood clots, wound infection, heart attack and a reaction to anesthesia during or after surgery.

Regardless of the hip model used during the hip replacement surgery, patients with artificial hips should be aware of potential injuries that may indicate that their hip device is failing. Generally, these complications occur about three months after surgery and may include:

Pain in the groin or leg
Swelling at or near the hip joint
Difficulty walking or a limp
A noise (like popping, grinding or squeaking) from the hip joint
Leg length discrepancy
Bone loss, or osteolysis
Infection
Local nerve damage with weakness or numbness

During everyday activities like walking or doing errands, the ball component moves against the cup. Over time, the surface starts wearing away and little particles or debris are given off. The debris remains around the hip joint and cause the bone around the implant to weaken, resulting in the loosening of the hip implant.

Tell me more about the Birmingham hip system.

Metal-on-metal hip implants consists of a head, stem and cup. There are two types of metal-on-metal hip implants:

Traditional total hip replacement systems
Resurfacing hip systems.

The Smith & Nephew Birmingham hip system is a resurfacing hip system and is different than total hip replacement surgery. In total hip replacement surgery, the entire worn-down femur is replaced with a prosthetic femur. In hip resurfacing, the femoral head is not removed. A metal cap is placed over the existing bone along with a matching socket made of metal. The metal socket is inserted into the pelvic socket, also known as the acetabulum.

With hip resurfacing, only a couple centimeters of the original bone is removed, allowing patients to keep most of their bone structure. Hip resurfacing can reduce the risk of hip dislocation and facilitate future replacement or revision surgery if required in the future.

The problem with the Birmingham hip system is the grinding of metal against metal, which leads to the accumulation of tiny particles of metal around the joint. Over time, these particles irritate the hip tissues, causing swelling, inflammation and fluid build-up. The metal ions can buildup in the blood stream, causing metal poisoning. This can lead to life-threatening systemic complications in other areas of the body.

For patients with Birmingham hip systems, dangerous side effects can arise, causing:

Metal blood poisoning
Tissue damage from metal debris
Earlier than normal failure of the hip replacement
Dislocation or device loosening
Bone fracture
Infection

Metallosis is another word for metal blood poisoning. This occurs when high levels of cobalt and chromium are in the bloodstream. This metal poisoning can cause:

Headaches
Dizziness
Nausea
Cobalt poisoning
Damage to the central nervous system

If you experienced any of the above-mentioned symptoms after hip replacement surgery, contact a healthcare professional immediately.

Who makes the Birmingham Hip resurfacing system?

Smith & Nephew is a U.K based medical technology company with headquarters in Memphis, TN. Birmingham hip resurfacing systems were introduced into the orthopedic market in 2006.

Smith & Nephew submitted the hip device through the FDA’s 510(k) Pre-market Notification Process. Under this 510(k) program, a medical device can be accessible to the public without being subject to clinical trials if it can be prove that the product is substantially similar to a device that has already received FDA approval. The Birmingham implant was approved as “substantially similar” because it was similar to other already sanctioned hip devices.

The Birmingham hip resurfacing system’s product safety did not have to be proven in advance by the hip manufacturer. Birmingham was only required to conduct post-market surveillance after the device was put on the market. One main problem with this 510(k) approval system is that side effects and dangerous complications can only be found after implantation in patients. Worse, the Birmingham hip device was modeled on systems that already were suspected of having significant design problems themselves — problems that led to premature failure rates and painful injuries.

Was the Smith & Nephew Birmingham hip recalled?

In June 2015, the Birmingham hip resurfacing system was pulled from the market due to studies showing the resurfacing system causes a high rate of patients undergoing revision surgeries to correct the numerous complications.

Are other Smith & Nephew hip systems voluntarily recalled?

Smith & Nephew manufacturers several hip replacement systems, including the SMF hip implants, the Redapt hip implants, and the R3 Acetabular hip system. Similar to the Birmingham hip recall, Smith & Nephew issued a worldwide, voluntary recall of the SMF, Redapt and R3 metal liners in June 2012, after reports of device loosening, hip pain, device failure, infection, sensitivity to metal and device dislocation.

Additionally, in November 15, 2016, Smith & Nephew issued a safety notice with a list of affected lots and products. The implants affected by the recall include those implants distributed between October 2008 and 2016. The company “initiated a voluntary market removal…due to a higher than anticipated complaint and adverse event trend,” according to the notice.

Be on Watch

If you or a loved one had a metal-on-metal hip device implanted since 2000 and experienced symptoms, you may qualify for financial compensation for medical expenses, medical treatment, loss of income, and injuries suffered.

Call us at (888) 458-6825 or send us an email inquiry to discuss your legal options.

The consultation is free and confidential.

Resources:

FDA recall June 3, 2015 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139519
FDA concerns about Metal-on-Metal Hip Implants https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm
Reuters metal allergies article June 20, 2014 https://www.reuters.com/article/us-joint-replacements-metals-allergy-idUSKBN0EV1TY20140620
The New York Times hip implant failure article January 22, 2013 https://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?_r=0