Smith & Nephew Hip Recall
Several Smith & Nephew hip implant devices have been subject to FDA recall including the R3 Acetabular system in 2012, Birmingham Hip Resurfacing (BHR) system in 2015 and the Modular SMF and Redapt Revision Hip systems in 2016.
The recalls were voluntarily issued after a large number of injury reports identified device loosening, dislocations, metallosis and early failure rates that were two or more times greater than expected.
Metal Components Responsible for Failures
Problems with the Smith & Nephew R3 and BHR devices have occurred mainly due the metal-on-metal (MoM) construction. Though MoM design is intended to be a more durable option, severe problems have resulted from possible grating of metal surfaces against one another. Grating of the metal surfaces has allowed for local tissue destruction and systemic metal poisoning in some Smith & Nephew hip implant recipients.
The MoM construction likely played a large role in the need for recall of the R3 Acetabular and metal liner and the Birmingham Hip Resurfacing devices.
Smith & Nephew Hip Recall
Hip replacement injuries and faulty replacement devices are one of the most common issues in the medical community. As much promise as hip replacement surgery offers some people, it causes others a great deal of pain and suffering. Many manufacturers of hip replacement devices have experienced problems, and Smith & Nephew is no exception.
Smith & Nephew is based in London and manufacturers replacement systems for shoulders, knees, and hips. They are the fourth largest manufacturer in the United States, despite having a number of issues with their various replacement devices. Recalls on their devices have been initiated voluntarily by Smith & Nephew, as well as by the FDA.
Two of the most recent recalls involved the Smith & Nephew R3 Acetabular system in 2012 and the Birmingham Hip Resurfacing (BHR) system in 2015. Both recalls were voluntary but may have resulted in thousands of hip implant failure cases.
The recalls were issued in response to problems with the device loosening, causing infection, dislocating, trigging metallosis, and failing completely. The average rate of early failure of hip replacement devices is just under 3%, but the R3 Acetabular has a more than 6% failure rate and the BHR rates may be higher.
Metal Components Destroy Surrounding Tissue
Smith & Nephew’s hip implant devices include a cup made from plastic, ceramic, or metal, a femoral head made from the company’s proprietary metal blend or ceramic, and a liner mad from the proprietary metal or plastic. The problems occur mainly with the metal-on-metal (MoM) device models. Though MoM construction is intended to be a more durable option, many have experienced issues due to possible grating of metal surfaces against one another.
Hip implant devices with metal liners made by Smith & Nephew are constructed of a cobalt-chromium blend. This blend has also been used in other replacement devices and is known to release metal chromium and cobalt ions into the body which may be absorbed into the bloodstream.
The ions from these metals are considered carcinogenic and have been linked to DNA damage and blood poisoning. Cobalt is also known to cause heart muscle disease. Research has shown the device itself does not cause metal toxicity in the body, but other complications can eventually lead to toxicity or metallosis. Even patients who initially respond well to the system could eventually have problems and require revision surgery.
When localized damage occurs in the tissue near the device, it leads to the destruction of muscle and bone of the joint. As the bone and muscle are destroyed, the device loosens and may fail. This can also cause a great deal of discomfort and a lack of mobility in users and may ultimately require revision surgery.
As a reason for voluntary recalls issued for the R3 Acetabular system, the Birmingham Hip Resurfacing system and the Modular SMF and Redapt systems, Smith & Nephew cited higher-than-expected adverse event or failure rates.
Read more about Smith & Nephew Hip Implant side effects.
Smith & Nephew Hip Implant Lawsuits
Smith & Nephew has faced thousands of lawsuit lawsuits regarding the R3 Acetabular device, most of which were quietly settled before 2015. The company has also faced hundreds more lawsuits for the Modular SMF, Redapt and Birmingham or BHR devices and still more may expected. Patients with Smith & Nephew hip implant devices are encouraged to notify their doctors if they experience any issues with pain, discomfort, lack of mobility and range of motion, flu-like symptoms, or other complication.
Smith & Nephew is a British-based multinational company with more than 11,000 employees in 90 countries. The annual sales in 2012 were more than $4.1 billion. The company specializes in orthopedic reconstruction, sports medicine, trauma and advanced wound management.
- ANTHOLOGYS Hip System
- BHRS Birmingham Hip Resurfacing
- R3 Acetabular System
- REDAPT Revision Femoral System
- SMFS Short Modular Femoral Hip
- VERILASTS Technology
- EMPERION Modular Hip System
- SPECTRON Hip System
- ECHELON Hip System
- CONQUEST FX Femoral Hip Implant
- TANDEM Hip System
- REFLECTION Acetabular Cup System
R3 acetabular system
The R3 acetabular system is the latest hip implant product introduced by Smith & Nephew in 2007. The acetabular system in combination with stems was designed to provide greater stability, wider range of movement, longevity and address the revision in case of failures. The R3 acetabular system consists of acetabular cup with a liner.
The complete hip replacement system comprises of:
- Hip stem
- Femoral head
- Acetabular cup
The R3 Acetabular component consists of an enhanced porous ingrowth surface to satisfy the needs of both primary and revision hip surgery. It has an optimized locking mechanism and the ability to accommodate polyethylene, metal, or ceramic liners. A study on the safety and efficacy of the new StikTite porous ingrowth surface claims to provide a superior “scratch-fit” due to its greater coefficient of friction and less micro motion. The high porosity StikTite and lower porosity Roughcoat surfaces provide excellent “biologic fixation”. The StikTite coating is designed to provide proper fixation and enhance the stability. This not only helps holding the weakened bone but also allows the normal growth of the bone. The R3 Acetabular Cup is designed for multiple weight bearing. The multi-bearing cup is engineered in a way to reduce wear and increase the life of the apparatus. The cup can support CoCr, OXINIUM and Biolex femoral heads and can hold larger cups for greater range of movements. The internal surface is usually lined by the Cross-linked polyethylene (XLPE) for reducing the friction, enhancing the stability and resilience. The R3 acetabular system allow the surgeon to select the material according to the need of patients.
Following are the important features of acetabular cup:
- Accommodation of Larger femoral heads for greater range of movements.
- Complementation between neck geometry and liner allow maximum head/shell ratios for optimal functioning.
- The liner equally surrounds the head from all sides, thus enabling the enhanced range of motions which ultimately reduces the risk of joint subluxation, nerve impingement, and prosthetic loosening—all contributors to revision surgery.
Recent modifications to R3 acetabular system include multi-hole shells with Constrained Liners and Big Femoral Heads.
The Liner is an articular surface between the head of femur and the acetabular cup. A good liner should be resilient, tough, erosion-free, and provide enough room for the femoral head. Smith & Nephew recommends the liner made of Polyethylene (XLPE or PEX) which is thicker at the apex and load-bearing areas. According to a 5 year study, the head penetration of a second-generation XLPE liner remained low at 5 years and the wear rate calculated after the first year was “low in all directions”. The liner is also engineered in a way to allow repositioning during the surgery.
When are hip replacements recommended?
Initially, treatment for degenerative joint diseases deals with the pain and other symptoms common for these types of joint problems. The initial treatment for pain management consists of steroids, anti-inflammatory drugs, pain killers and local injections.
After failure of all these treatments, total hip replacement is the last resort to rehabilitate the patients suffering from:
- Osteoarthritis as a result of antigen-antibody reaction
- Traumatic arthritis as a result of inflammation after trauma
- Avascular necrosis due to compromise in blood supply
- Fused hip joint due to inflammatory scarring or any other cause
- Slipped capital epiphysis due to shear stress
- Fracture of the pelvis and diastrophic variant.
The diverse varieties of Hip components are also used for degenerative joint diseases which include:
- Rheumatoid arthritis (an autoimmune attack)
- Arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia;
- Treatments of non-union
- Femoral neck fracture (trauma)
- Fractures of the trochanter of femur along with head involvement
- Fracture-dislocation of the hip
- Correction of deformity
Harmful Effects of R3 Acetabular System
The harmful effects of R3 acetabular system with metallic liner are diverse and include:
It is very common complication especially in the younger patients. Almost 20% of patients complain of post-operative pain at the site of implantation. It is usually associated with signs of inflammation i.e. redness, tenderness, swelling, warmth etc.
The deposition of metal debris resulting in increased plasma concentration of metals, results from shaving off metals by friction. In a recent study, it was demonstrated that almost all the patients suffer from severe metallosis after 10 year of metal-on-metal implant. The larger cup size increases the likelihood of developing severe metallosis.
Revision Surgery After Device Failure:
There are a variety of problems than can lead to revision surgery. Mechanical failure, infection and recurrent hip dislocation can all prompt a doctor to consider a revision surgery. Often the revision surgery is more dangerous than the initial surgery and can further damage the area of the implant.