Omni Apex K2 Hip Implant LawsuitDecember 4, 2015 — A study published in the Journal of Arthroplasty has linked the Apex K2 hip replacement with a risk of metal corrosion.

Researchers tracked outcomes for 95 patients who were implanted with the Apex K2. The study suggested high rates of loosening, migration, fretting, and corrosion. At least two patients developed deep joint infections and needed revision surgery.

Other patients developed a condition called aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL). Symptoms often include chronic pain, soft-tissue growths known as “pseudotumors,” allergic reaction, inflammation, and metal poisoning.

In October 2012, the Australian Therapeutic Goods Administration (TGA) cancelled approval for the Apex K2 Femoral Stem after an analysis of data from the Australian National Joint Replacement Registry (NJRR) linked it to a 5.5% failure-rate after one year, and 9.3% after three years.

The Apex K2 is a modular hip replacement made by OMNI Life Sciences. It consists of a metal femoral stem and interchangeable neck and head components that allow a surgeon to custom-fit the implant to each patient.

It was approved by the FDA in 2004 under the 510(k) clearance process, which allows new devices on the market without requiring new safety studies so long as they are similar to an approved device. This process has been criticized for allowing thousands of defective metal-on-metal hip replacements on the market.

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