Smith & Nephew Metal on Metal R 3 Hip Recall

There was a Smith & Nephew hip recall issued on June 1, 2012. The British hip manufacturer recalled the optional metal liner component of its R3 Acetabular System hip device due to high failure rates associated with the device.

According to statements on its website, "The company has chosen to withdraw the optional metal liner component within the R3 Acetabular System as a precautionary measure following a review of the most recent data. Data collected, including data from the Australian and UK patient registries, indicated the metal liner component within the R3 Acetabular System is not performing as well as we would like."

Studies Indicate Higher Revision rates

Annual revision rates in patients with the Smith & Nephew metal liner component were 1.6 percent, which is well above the 1 percent rate Britain’s National Institute for Health and Clinical Evidence deems acceptable.

Scope of the problem

The metal liner was introduced to the market in 2007, and globally launched in 2009. Approximately 7,700 individuals were affected by the Smith & Nephew hip recall.

The optional metal liner component within the R3 Acetabular System received FDA Pre Market Approval in November 2008 for use with the BHR Hip resurfacing head. For total hip replacement, it received CE approval in Europe for market evaluation in January 2007 and for full launch in December 2007, and it was included on the Australian Register of Therapeutic Goods in January 2007.

What are the problems?

Potential complications from the device include infections, fractures and dislocations, though the company maintains that there is no evidence of the device causing metallosis, or increased metal debris in the body.

This latest device recall adds to increasing concerns about the safety of metal-on-metal hip implants. In August 2010, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a voluntary worldwide recall of its ASR hip replacements that affected approximately 93,000 people after data revealed that the devices had excessively high failure rates.

According to a recent report by the British Medical Journal and the BBC, hundreds of thousands of people worldwide may have been exposed to high levels of toxic cobalt and chromium ions that can seep into tissues and destroy muscle and bone, leaving some patients with long-term disability. Studies also show that metal ions can seep into the bloodstream, spreading to the lymph nodes, spleen, liver and kidneys.

British regulators recommend lifetime monitoring

In the U.K., 65,000 metal-on-metal implant operations have taken place since 2003, according to the Medicines and Healthcare products Regulatory Agency (MHRA).

The ASR Acetabular implant from J&J’s DePuy Orthopaedics Inc. unit was removed or replaced 29 percent of the time after six years, compared with a 9.5 percent failure rate for all metal-on-metal implants, the National Joint Registry of England and Wales said in September.

The MHRA recommended that doctors conduct annual magnetic resonance imaging scanning for the life of implants that are 36 millimeters (1.4 inches) or larger. This updates guidance issued in April 2010 that patients be monitored for at least five years after the operation.

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