MicroPort—Various Metal-on-Metal Total Hip Arthroplasty Components: May Be Associated with Tissue Reaction to Metal Debris
July 27, 2016 | Risk Management News
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In a July 12, 2016, Urgent Field Safety Notice letter submitted by an ECRI Institute member hospital, MicroPort states that the above components may be associated with a risk of tissue reaction to metal debris. The firm observed an increase in revisions from 2009 to present. Microport states that the typical impairment of tissue reaction is reversed by revision surgery to remove the old device and replace it with a new device. MicroPort also states that it has updated the instructions for use (IFU) for the above component families in the U.S. The manufacturer has not confirmed the...