U.S. FDA to Collect Adverse Event Data Despite UK Recall of Metal Hip Implants

Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the U.S. Food and Drug Administration (FDA) says. National Joint Registry of England and Wales data, which last year showed high revision rates for two ASR hip resurfacing systems, led to a UK medical device alert and recommended blood tests, as well as a worldwide J&J recall in August. But the FDA argues the adverse event rate for these devices remains unclear, and the agency is in the process of gathering additional information about adverse events in people with MoM hip implants.
International Medical Device Regulatory Monitor