Outcome Data Drives S&N’s Metal Cup Recall

In short

News agency Reuters has reported the voluntary recall of one component of Smith And Nephew’s R3 Acetabular Hip Prosthesis System which it says will add to concerns about the safety of metal-on-metal hips. For its part, Smith & Nephew said on Friday the issues with its system were different to those seen with some other all-metal implants and pointed out that only 1.6% of patients needed revision compared with a NICE guideline of 1%.

Background

Metal-on-metal (also known as all-metal) hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket. In theory these implants were pitched at the younger patient for whom a longer-lasting implant would have clear benefits. However, readers of our site and in fact most of the world’s medical media, will be well aware of the emergence of problems with some all-metal bearing surfaces, most notably resulting in the high-profile recall of Johnson & Johnson DePuy’s ASR product.

In a move which is sure to be seen as just a bit more fuel for the fire, Smith & Nephew is withdrawing the optional metal liner, or cup, component of its R3 Acetabular System. Surgeons will still be able to use the system using alternative non-metal liners and the company said it did not anticipate any delays to surgery.

The decision follows an analysis of clinical results showing that 1.6 percent of patients with the system needed revision surgery each year, which is above the 1 percent guideline set by Britain’s National Institute for Health and Clinical Excellence.

Approximately 7,700 of the metal liners have been implanted since the component was introduced in 2007. Procedures using the component accounted for less than 1 percent of Smith & Nephew’s global hip implant revenue last year.

This reliance on clinical data supports the contention that greater reliance on registries of implanted devices is likely to be a key component in any changes to the way regulators go about ensuring patient safety in a world that needs to be seen to be encouraging new technology.

Company comments

“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” said Andy Weymann, Smith & Nephew’s Chief Medical Officer.

A small number of patients experienced problems including infections, fractures and dislocations – but there was no evidence of “metallosis”, or the build-up of metallic debris in the body, a spokesman said.

Source: Reuters