Parker Waichman attorney Gerard Ryan gives an update on Smith & Nephew’s metal-on-metal hip implant in the above video. Smith & Nephew, the first company to market the new generation of metal-on-metal hip implants, is the latest company to face safety issues over metal-on-metal hip replacements. As with other brands of all-metal hip implants, new data shows that the rate of revision for Smith & Nephew’s Birmingham Modular Head is higher than guidelines established by regulatory bodies. The company issued a new warning in response to the information, modifying indications for using the implant.
Smith & Nephew issued an Urgent Field Safety Notice warning that the rate of revision for the Birmingham Hip Modular Head fails more often than recommended by British and Australian regulators. The National Joint Registry of England and Wales and the Australian Orthopaedic Association’s National Joint Replacement found a revision rate of 1.29 percent and 1.12 percent, respectively. Both of these statistics exceed the 1 percent guideline established by the UK’s National Institute for Health and Clinical Excellence. The Safety Notice also states that the metal hip implant is associated with pain and limited mobility, complications that could potentially lead to revision surgery. The indications for the device have been updated to restrict its. New indications include patients undergoing revision surgery who have no signs of metal sensitivity, resurfacing procedures where the cup remains in place and is not a factor in the revision, and in combination with the company’s uncemented Synergy stem.