Smith & Nephew (S&N), a British company that was one of the first makers of metal-on-metal (MoM) hip implants, has issued an “Urgent Field Safety Notice” concerning the Birmingham Hip Modular Head implant. Issued to the Hong Kong Department of Health, S&N reported the failure rate exceeds the 1 percent benchmark established by the United Kingdom.
In data gathered since 2010 from the National Joint Registry of England and Wales, the failure rate of the implant was 1.29 percent and 1.12 percent based on the Australian Orthopaedic Association National Joint Replacement Registry.
The company said its highest priority is to deliver safe and effective medical devices and it’s notified regulatory bodies and customers of, “a change to the indications” for use of the Hip Modular Head, used in total hip replacements.
However the company stopped short of issuing a recall. Smith & Nephew said when used with the S & N Synergy stems, the failure rate was a more acceptable 1.07 percent.
In a letter to healthcare providers, the company said patients may experience, “pain and limited mobility, potentially leading to revision surgery. Females of child bearing age are at greater risk with metal-on-metal implants. Severely overweight individuals have been observed to be at greater risk of revision surgery.”
Where does this news leave doctors and patients?
S & N says the Birmingham Hip Modular Heads should be used only in the case of a revision surgery or when the patient shows no sign of metal sensitivity or has an uncemented Synergy stem or a Birmingham Hip acetabular cup.
In the U.S., the Birmingham Hip Modular Head does not have FDA approval to be used in a primary hip replacement.
Its cousin, the Birmingham Hip Resurfacing (BHR) implant, which is used in the U.S., is not affected by this action, however, one of our clients who received the BHR spent 10 months in the hospital near death from the amount of infection surrounding the hip implant.
In 2006 it was approved by the FDA and the BHR remains on the market despite the many complications associated with it similar to other MoM hips including metal debris, pseudotumors, auto-immune reactions, and necrosis of the muscle and tissue, among other complications.
The inventor, Dr. Derek McMinn walked away with more than $100 million when he sold the device to Smith & Nephew and the MoM industry erupted with the Zimmer Durom, and Johnson & Johnson DePuy ASR models.
On August 24, 2010, Johnson & Johnson voluntarily recalled the DePuy ASR total hip system because studies from the UK showed a 13 percent revision rate within five years. On July 22, 2008, the Zimmer Durom Acetabular Component (Durom Cup) was voluntarily recalled because of inadequate instructions for use and surgical technique, according to the FDA. That doesn’t reflect well on the S & N original MoM device that served as the model for the Durom and ASR.