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The EMPERION Modular Hip System metal-on-metal hip joint replacement device is utilized in primary and revision surgeries of patients afflicted with damaged hips. It is manufactured by Smith & Nephew Inc. of Memphis, Tennessee, and initially approved by the U.S. Food and Drug Administration (FDA) in November, 2004.
The device, designed to be implanted without cement, may be used in primary or revision hip replacement cases where the rehabilitation of hips damaged by fracture, a noninflammatory degenerative or inflammatory joint disease, or trauma has proven unsuccessful.
The EMPERION Modular Hip System has a modular stem made from a titanium alloy (Ti-6Al-4V). Its neck is circulotrapezoidal in shape. Cylindrical and polished, the sleeves of the EMPERION Modular Hip System are coated with a porous hydroxyapatite surface material.
Smith & Nephew states that this particular stem configuration and construction reduces stress-shielding and micromotion.
Smith & Nephew EMPERION Variations
The stem of the EMPERION Modular Hip System, which is press-fit into position, is available in primary, standard revision and bowed long-revision lengths.
Additionally, the EMPERION Modular Hip System is available with progressive offset options, distal flutes, a coronal slot and a polished bullet tip.
According to various studies, corrosion potentiation has been observed at the modular junctions of metal-on-metal total hip arthroplasty devices, such as the EMPERION Modular Hip System.
Smith & Nephew EMPERION Health Complications
The EMPERION Modular Hip System is suspected of causing health complications for a number of patients, specifically implant fractures.
A growing body of scientific literature has focused on corrosion as a possible significant cause of these health complications. According to various studies, corrosion potentiation has been observed at the modular junctions of metal-on-metal total hip arthroplasty devices, such as the EMPERION Modular Hip System.
Frank et al. 1 identified and explored a case in which a total hip arthroplasty patient experienced a fracture of an EMPERION Modular Hip System at the stem and sleeve modular junction. In addition, the authors found corrosive material near the implant fracture and adverse local tissue reaction, “suggesting that micromotion at the modular junctions along with particulate debris from the MOM [metal-on-metal] articulation” may have contributed to the patient’s fracture.
Fretting, corrosion and metal debris “may synergistically contribute to a local environment conducive to junctional fatigue failure in dual-modular femoral stems,” the authors wrote.
Smith & Nephew EMPERION Alerts and Warnings
As of July 10, 2015, there has been no FDA Safety Alerts or Warnings for the EMPERION Modular Hip System.
However, there have been a number of fracture and revision reports made to the FDA Manufacturer and User Facility Device Experience (MAUDE) database. 2 In addition, the Australian Orthopaedic Association National Joint Replacement Registry, whose purpose is to “define, improve and maintain the quality of care of individuals receiving joint replacement surgery” in Australia and its states and territories found a significantly higher cumulative revision hazard ratio of 1.90 for the EMPERION. 3 4
Rachel M. Frank, Debdut Biswas, and Brett R. Levine, “Fracture of a Dual-Modular Femoral Component at the Stem–Sleeve Junction in a Metal-on-Metal Total Hip Arthroplasty,” American Journal of Orthopedics, 57-60, March 2014. ↩
EMPERION MAUDE Database Search, Dec. 1, 2004 through May 14, 2015. ↩