The family of a Maryland woman who died following revision surgery to replace what they claim were defective Stryker hip replacement components, including the LFIT V40 femoral head and Accolade II femoral stem, has filed a new lawsuit seeking compensation for her alleged wrongful death.
According to a complaint filed in the U.S. District Court, District of Maryland, on March 9th, Rosezetta Engle received the Accolade II Femoral Hip Stem and V4 Taper LFIT Anatomic CoCr Femoral Head during right hip replacement surgery in 2011. (Case No. Case 1:18-cv-00710)
After experiencing pain and following an evaluation by her physician, Engle underwent a risky revision surgery to remove and replace her hip components. During the January 2015 procedure, her surgeon noted “significant necrosis and fluid within the hip and gluteus minimus,” as well as “corrosion and black staining under the ball and surrounding taper.”
Engle died on March 11, 2015, allegedly due to a post-operative infection she developed as a result of her revision surgery.
“Defendants’ Accolade II Stem and LFIT V40 Cobalt Chromium femoral head are designed in such a way that, when used as intended in combination, it causes serious, permanent and devastating damage to patients in whom the devices are implanted,” the complaint states.
Engle’s family asserts that the risks associated with use of the LFIT V40 femoral head- Accolade II femoral stem combination outweighed any potential benefits. They further charge that she and her doctors would have never chosen to use the components had adequate warnings of those risks been provided by the defendants.
In addition to Accolade stems, Stryker’s LFIT Anatomic CoCr V40 Femoral Heads were designed for use with a number of other modular hip stems, including the
In August 2016, Stryker issued a worldwide recall for certain LFIT V40 femoral heads manufactured prior to 2011. According to the company, the recall was precipitated by an unusually high number of complaints involving taper-lock failure.
Patients fitted with the recalled components are at risk for the following:
The U.S. Food & Drug Administration would later designate the Stryker hip recall a Class II medical device recall, the agency’s second most serious classification.
Since announcing the LFIT V40 femoral head recall, Stryker has been named a defendant in dozens of hip replacement lawsuits filed on behalf of individuals who allegedly suffered debilitating injuries and complications related to failure of the component.
Close to 150 Stryker hip lawsuits involving LFIT V40 femoral heads have since been centralized in Bergen County Superior Court. Another 223 cases are undergoing coordinated pretrial proceedings in the federal litigation now underway in the District of Massachusetts. Additional claims are pending in state courts throughout the country.