W&L is investigating cases of fracture associated with the EMPERION Modular Hip System manufactured by Smith & Nephew Inc. of Memphis, Tennessee.
The investigation was prompted by recent medical literature, fracture and revision reports discovered in the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, and an analysis by the Australian Orthopaedic Association National Joint Replacement Registry that found a significantly higher cumulative revision hazard ratio of 1.90.
Although not called EMPERION when the FDA initially approved the device in 2004, the EMPERION Modular Hip System is indicated for uncemented use in individuals undergoing primary and revision surgery.
Typically, the cause of such damage to hips may include trauma, fracture, a noninflammatory degenerative joint disease or an inflammatory joint disease, such as rheumatoid arthritis.
“The cumulative percent revision of the EMPERION Modular Hip System when compared with other conventional hips was calculated in the Australian Orthopaedic Association’s National Joint Replacement Registry to be significant,” said Ellen Relkin, of counsel attorney.
The EMPERION Modular Hip System is a titanium alloy (Ti-6Al-4V) press-fit modular stem that has a circulotrapezoidal neck. It comes in three stem lengths. They are: primary, standard revision, and long revision. The long revision is bowed.
The EMPERION Modular Hip System is cylindrical and polished, with a hydroxyapatite porous coating applied on all sleeves. The manufacturer states that the neck features optimized neck geometry, progressive offset options, distal flutes, coronal slot and a polished bullet tip.
Smith & Nephew states that its EMPERION Modular Hip System was designed to address a spectrum of anatomical variants of the sort likely to be encountered during either primary or revision hip arthroplasty.
Smith & Nephew markets the EMPERION Modular Hip System as a device capable of providing enhanced range-of-motion and fewer dislocations.
Controversy Surrounding EMPERION
As the EMPERION Modular Hip System has been used, concerns about corrosion potentiation at modular junctions and implant fractures have arisen.
For example, in one case, a fracture at the modular stem-sleeve junction in a patient implanted with an EMPERION titanium press-fit dual-modular femoral component in a metal-on-metal total hip arthroplasty was the subject of a medical journal article in The American Journal of Orthopedics by Dr. Rachel M. Frank, et al. In addition to the fracture, the authors found corrosive material near the implant fracture and adverse local tissue reaction that suggested to them “that micromotion at the modular junctions along with particulate debris from the MOM [metal-on-metal] articulation may have subsequently contributed to a fatigue fracture in this patient.”
The authors noted that though modularity is often touted as a benefit in hip implants, it “leads to more junctions where particulate debris may be generated and corrosion may occur.”
They also noted that the effects of fretting, corrosion and metal debris “may synergistically contribute to a local environment conducive to junctional fatigue failure in dual-modular femoral stems.”
Compensation for EMPERION Harm Possible
Patients who have received an EMPERION Modular Hip System manufactured by Smith & Nephew should contact W&L with questions related to this device or to discuss concerns about this implant. In some cases, patients may have already had, or need, revision surgery.
It is possible that a patient who received an EMPERION Modular Hip System may be entitled to reimbursement for the cost of corrective surgery, hospitalization and related medical services.
A patient may also be entitled to compensation for lost income, a harm that can occur as a result of having to receive corrective surgery and then being sidelined from work while recovering from the medical procedure.
Other forms of compensation also may be available.
To arrange a free consultation, contact W&L by calling (800) 476-6070 or reach us online by using our form or live chat.