Weitz & Luxenberg is currently accepting cases from people harmed by a faulty shoulder replacement device made by Zimmer Biomet. The medical device manufacturer issued…Read More
W&L Taking OMNIlife Science Apex K2 Modular Hip System Injury CasesNov. 25, 2015
Weitz & Luxenberg, P.C., is now accepting cases involving total hip arthroplasty patients who have been implanted with an OMNIlife science Apex K2 Modular Hip System hip implant.
W&L began investigating these cases after reports of patient injuries appeared in medical journals. There was also a reported rate of revision in the Australian Orthopaedic Association National Joint Registry that was higher than expected, said W&L’s Ellen Relkin, of counsel attorney.
“It appears these injuries stem from corrosion and fretting complications of the implanted OMNIlife science Apex K2 Modular Hip System, which gives rise to potentially serious complications, including the necessity of revision surgery,” Ms. Relkin said.
The higher rate of failure of the OMNIlife science Apex K2 Modular Hip System may manifest in the form of loosening, subsidence, migration, fretting, corrosion or some combination of these.
These, in turn, could potentially lead to fracture or metallosis.
The Apex K2 is sometimes placed in patients for whom a primary or revision total hip arthroplasty is medically indicated. The FDA-approved indications are:
- Noninflammatory degenerative joint diseases, including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Congenital dislocation
- Revision procedures where other treatments or devices have failed
- Femoral neck and trochanteric fractures of the proximal femur
The FDA approved the Apex K2 in 2004 after receiving from the manufacturer a 510(k) application to begin marketing the device. The Apex K2 Modular Hip Stem 510(k) application was submitted by Apex Surgical, LLC, a company that was acquired by OMNIlife science, Inc. in 2004.
Approval of a 510(k) application typically requires the manufacturer only demonstrate that the product to be marketed is substantially equivalent to a predicate product the FDA has previously approved.
OMNIlife Science Apex K2 Modular Hip System High Failure Rate
The OMNIlife science Apex K2 Modular Hip System consists of a femoral stem, modular neck and a modular head. The stem and neck are constructed of titanium alloy.
The FDA has not at this time ordered a recall of the OMNIlife science Apex K2 Modular Hip System. Nor has the manufacturer voluntarily initiated one.
However, the regulatory body equivalent to the FDA in Australia, the Therapeutic Goods Administration (TGA), in 2012 cancelled its own approval of the Apex K2 in that country because revision surgery rates were unexpectedly high.
An article published in the Journal of Arthroplasty investigated potential problems surrounding these hips. As the study authors note, the hip components are titanium “except for a ‘Dual-Press’ modular connection at the stem/neck interface…which incorporated a cobalt-chromium anti-rotation peg.” This area in several explanted hips that required revision was found to have “crevice corrosion” and “was associated with ‘greeny’ deposits adjacent to the point of pin insertion” in some cases. Analysis of other revised hips revealed similar metal related pathology.
The journal article, by Michael Kent and colleagues, also observed “potentially concerning subsidence and retroversion” as well as “significant and continuing migration…associated with increased risk of revision.”
W&L Can Help Hip Replacement Patients
Patients who have received an Apex K2 Modular Hip System and have experienced problems with their device should contact W&L.
Patients injured by an Apex K2 Modular Hip System may be entitled to compensation for the cost of revision surgery, hospitalizations and related medical services.
Additionally, patients implanted with and injured by an Apex K2 Modular Hip System may be entitled to compensation for lost income during the time absent from work while recovering. Other forms of compensation also may be available.
To arrange a free consultation, contact W&L by calling (855) 274-5624 or reach us online by using our form or live chat.