Hip Replacement Injury Risks

Metal-on-Metal Hip Implant Risks and Injuries

There is substantial documented evidence that metal-on-metal hip implant devices can cause a variety of unique complications beyond the “typical” complications that may arise from hip surgery. The primary complication is a condition called Metallosis which is a form of metal poisoning. When the two components that comprise the hip implant, i.e. the metal ball and metal socket, slide against each other during routine movement such as walking and running, tiny metal fragments can be released. These tiny metal particles can get trapped in healthy tissue surrounding the implant causing tissue and bone damage. In some cases, cobalt and chromium ions from the implant itself or the released metal particles can enter the bloodstream causing metal poisoning.

Several medical device manufacturers have introduced metal-on-metal hip implant devices. Smith & Nephew had two devices approved by the FDA in 2006, the R3 liner (never FDA approved for total hip replacement) and the Birmingham Hip Resurfacing (“BHR”) System (FDA approved for use with the R3 liner). Both devices were composed of metal and both have been associated with a high failure rates resulting in hip revision surgery, as well as other severe complications including metal toxicity. DePuy Orthopaedics, a subsidiary of Johnson & Johnson, had their ASR system voluntarily recalled in August of 2010 due to an abnormally high device failure rate and complications that resulted from the device’s metal-on-metal components. Despite the recall of their ASR system, the company continues to sell the metal-on-metal components in their Pinnacle line resulting in thousands of outstanding claims against the company.

Summary of Injury risks associated with Metal-on-Metal hip implants:

Metallosis:

A form of metal poisoning developing after there is an excessive build-up of metal particles in the soft tissue surrounding the hip implant or when metal ions of cobalt and chromium enter the bloodstream.

Adverse local tissue reaction (ALTR):

Adverse reaction in the tissue and bone at the implant site from elevated cobalt and chromium metal ions being released into the tissue and/or bloodstream. Adverse reactions can include fluid accumulation, infection, bone loss and/or bone fracture and the death of healthy tissue. This condition is cited as one of the most common metal related complications following metal-on-metal hip replacement surgery.

Metal-on-Metal pseudotumour:

A severe complication that occurs when a solid mass forms in the surgical area from a tissue reaction to the metal in the hip implant device. This condition is typically seen in individuals with elevated metal ion levels.

Bone Loss (also referred to as osteolysis):

Can occur when loose metal particles from the implant activates the immune system. This causes an inflammatory response which in turn can lead to bone loss and other severe complications.

Nervous System Disorders:

High blood level concentrations of cobalt and chromium can affect brain structure and function, contribute to depression and memory loss and lead to other neurological complications including auditory and visual impairment.

Smith & Nephew Hip Implant Recall

Although previously approved by the FDA in 2006, Smith & Nephew has recalled 2 devices due to extensive reports of complications from metal poisoning, higher than expected failure rates and other severe injuries requiring hip revision surgery and other corrective treatments. They are: The R3 metal-on-metal liner (“R3”) – Recalled in June 2012 and the Birmingham Hip Resurfacing (“BHR”) System - Recalled in September 2015

DePuy Orthopaedics ASR Hip System Recall

First made commercially available in the United States in December 2005, Depuy’s ASR XL Acetabular Hip System was voluntarily recalled in August 2010 after it was found that previously unpublished data from a joint replacement registry in the UK showed that the rate that ASR patients required a second surgery (or revision surgery) was not in line with data that had been reported to the registry and was the numbers were abnormally high.

If you or a loved one have experienced injuries or complications following a total hip replacement or hip resurfacing surgery involving a metal-on-metal hip implant device, we would like to speak with you.