FDA to evaluate Metal-on-Metal adverse event data – UK problems may be overstated

FDA to Collect Adverse Event Data Despite UK Recall of Metal Hip Implants (FDA News) 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 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 ...


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