SMITH & NEPHEW METAL-ON-METAL TOTAL HIP REPLACEMENTS

Smith & Nephew is the world’s fourth-largest producer of orthopedic reconstruction products. This multinational medical equipment manufacturer based in London, England sells their products in over 90 countries—including the United States. Their product catalog has included several defective metal-on-metal hip replacement systems, several of which have been recalled. As a result of malfunctions in these defective devices, many patients who have received these defective surgical implants have needed dangerous, painful, and costly revision surgery to correct the damage done.

SMITH & NEPHEW THA HIP IMPLANTS

A traditional total hip replacement is often referred to as a “THA,” which stands for Total Hip Arthroplasty.  Smith & Nephew sold several defective THA metal-on-metal hip implant products.  Although the designs varied slightly, the problem was the same.  The friction of the metal-on-metal components rubbing against each other caused metal particles to rub off and be absorbed into the body, often causing serious medical complications.

THE R3 SYSTEM

One of the Smith & Nephew defective metal-on-metal THA products was the R3 Acetabular Total Hip Replacement System.  This system used a metal acetabular cup and a metal femoral head, and featured a metal liner between the two.  The R3 cup was placed in the thigh bone (acetabulum) and the femoral component was a stem, which was implanted into the hip bone (femur).  A metal liner was placed between the cup and the top of the femoral stem, often referred to as the head or the ball.  Smith & Nephew issued a recall of the metal liner used in the R3 Acetabular Total Hip Replacement System in June 2012. The R3 System failed at a higher-than-normal rate—forcing hundreds of patients to undergo revision surgery. After the recall, Smith & Nephew issued what was supposed to have been a precautionary “hazard alert” to those doctors who had prescribed this system to their patients.

MODULAR HEAD  THA SYSTEM

In addition to the R3, Smith & Nephew promoted the use of a THA metal-on-metal system that used a BHR (Birmingham Hip Resurfacing) Acetabular Cup, combined with a modular femoral head, a modular sleeve, and a femoral stem, usually a Synergy or Anthology stem.  The head and sleeve were never approved for use by the FDA for use in THA’s. The BHR Cup was part of a different type of Smith & Nephew hip replacement system known as the BHR resurfacing that did not use a femoral stem.  Certain components of the BHR system were recalled in 2015 because it also failed at higher-than-normal rates and forced patients to undergo revision surgery.

THE MODULAR SMF AND REDAPT SYSTEMS

Other Smith & Nephew metal-on-metal THA systems that failed and resulted in a recall include the modular neck component used in the SMF (Short Monolithic Femoral) and Redapt hip products.  Both these systems have metal neck pieces (chromium and cobalt) that combine with metal (titanium) stems.  Smith & Nephew recalled the neck component in 2016 based on a “higher than anticipated complaint and adverse event trend” that posed the potential for “a greater risk of revision surgery.”

Known problems with all these Smith & Nephew THA systems resulted from the metal-on-metal design of the products. Metal surfaces of individual components rub against each other during normal use—leading to metal erosion. This erosion released metal particles—including Cobalt and Chromium—into the patient’s bloodstream and surrounding tissue. These particles, called ions, can lead to a buildup of metal debris that causes tissue, bone, and muscle damage around the implant.  This can lead to complications that include loosening and failure of the device, dislocations, and femoral fractures.  The elevated concentrations of chromium and cobalt absorbed into the body often results in metallosis, a type of metal posioning. This medical condition has many severe side effects, including:

• Severe hip and leg pain

• Tissue, bone, and muscle damage

• Pseudotumors 

• Reduced joint mobility

• Joint Dislocation

• Early device failure

• The need for revision surgery

The True Cost

When patients must undergo painful and costly revision surgery following the implant of a faulty medical device, the corporations responsible for manufacturing and marketing these defective products must be held accountable. If you have been injured due to a defective Smith & Nephew metal-on-metal hip implant device, time may be running out to file a claim for damages.