The study focused on 80 patients who had undergone prior MoM surgery and now required a revision. These revisions were conducted over a seven year period from February, 2003 through October, 2010. The study concluded that early failures were most often attributed to:
• Aseptic loosening (56.25%);
• Infection (12.5%);
• Metal hypersensitivity reactions (6.25%);
• Failed resurfacing (6.25%); and
• Fracture (5.0%).
As noted above, the considerable majority of MoM implants failed within two years; 78% of patients needed revisions within two years of their initial surgery, and 92.5% within three years.
These findings are in line with a recent release by the U.S. Food & Drug Administration (“FDA”) conceding that it had received 16,800 negative event reports involving metal hips between 2000 and 2011. Of the 16,800 reports, over 14,000 incidents required revision surgery.
These statistics only bolster mounting calls for more hands-on monitoring of and follow-up with MoM patients soon after their initial surgery.