New Stryker hip replacement lawsuits are being filed by plaintiffs injured by the LFIT V40 femoral head, a component of their hip implant. Some are calling this new group of lawsuits the “second wave.”
Stryker has been defending lawsuits involving its Rejuvenate hip stem and ABG II modular hip stem since 2012, when they voluntarily recalled these systems due to potential risks associated with fretting and/or corrosion at the modular-neck junction.
In January 2013, the New Jersey Supreme Court consolidated all state court cases in Bergen County, to be handled as multicounty litigation. That same year, federal cases were consolidated in the District of Minnesota.
Now, new cases are coming into these and other courts as plaintiffs start to experience problems with the LFIT V40 femoral head component, and learn of Stryker’s recent recall of these device components.
Stryker Issues Recall of Components Manufactured Prior to 2011
On August 29, 2016, Stryker issued an urgent medical device recall notifying orthopedic surgeons that they had received “higher than expected complaints of taper lock failure” for specific lots of the product. Potential hazards include disassociation of the femoral head from the hip stem, and excessive metal debris.
They added that the notification was related to femoral heads manufactured prior to 2011, stating it was “highly unlikely” that any of the components would still be “in the stockroom of any surgical center” or other medical facility. They did advise surgeons to hold any components that they may have pending return to Stryker. The majority of the femoral heads are already implanted in hip replacement recipients, however, and “therefore cannot simply be packaged up and sent back to the manufacturer.”
Instead, doctors have been advised to warn patients of the potential risks, and to follow- up with any that received the LFIT V40 femoral head to watch for symptoms of problems.
Corrosion Occurs at Head-Neck Juncture of Stryker Component
Stryker advertised the LFIT Anatomic CoCr Femoral Heads designed to minimize the risk of recurring dislocation, while maximizing hip movement and stability. Within a few years of the products being on the market, however, reports suggested they were at increased risk of metal wear and tear, which could increase the risk of weakening and breakage in the “taper lock” at the head-neck junction.
A number of studies have found that metal corrosion can occur in this area of the implant, causing pain, adverse tissue reactions, pseudo tumors (non-cancerous growths), and osteolysis (bone destruction). In a 2016 study review, researchers acknowledged that this type of gradual wear and tear was “a growing cause of total hip arthroplasty failure.”
Over time, as the juncture becomes weaker, patients may suffer decreased mobility and instability; without treatment, bone fracture and dislocation. All of these conditions require revision surgery to fix the implant.
Some plaintiffs have already filed lawsuits involving the LFIT V40 component. Now that Stryker has recalled the components, however—and now that some of these components are starting to cause problems in patients—it is expected that more lawsuits will be joining the current Stryker litigation.