December 4, 2015 — After the Omni Apex K2 hip implant was linked to a 9.3% three-year failure-rate, a study published in the Journal of Arthroplasty has found evidence of metal corrosion at the neck-stem interface.
Researchers looked at outcomes for 95 people who were implanted with the Apex K2. Two patients required revision surgery due to deep joint infections. Other Apex K2 implants failed due to loosening, migration, fretting, and metal corrosion.
At least one patient developed “pseudotumors,” also known as aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL). The condition may involve soft-tissue growths, chronic pain, inflammation, hypersensitivity reactions, metallosis, and more.
The Apex K2 was linked to a 9.3% three-year failure-rate, and a 5.5% failure-rate within one year, based on data from the Australian National Joint Replacement Registry (NJRR). Soon afterward, health officials in Australia cancelled approval for the implant.
No recalls have been issued in the United States. The manufacturer, Massachusetts-based OMNI Life Sciences, received approval for the Apex K2 in 2004 under the 510(k) process. This process allows new devices on the market that are “similar” to existing devices, without requiring new safety studies.
Unlike traditional metal-on-metal hip implants, the Apex K2 is a modular hip replacement with interchangeable metal parts. This design allows a surgeon to custom-fit the implant to each patient. However, corrosion and fretting can potentially occur between the metal femoral stem and components of the femoral head or neck.
Do I have an Apex K2 Hip Implant Lawsuit?
The Schmidt Firm, PLLC is currently accepting Apex K2 induced injury cases in all 50 states. If you or somebody you know was injured by a hip implant that failed, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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