Plaintiff Mark I. and his wife have filed a a Stryker LFIT CoCr V40 lawsuit against hip implant manufacturer Howmedica Osteonics Corporation, doing business as Stryker Orthopedics.

Mark says he underwent a total left hip replacement surgery on Dec. 2, 2011. After implantation, he developed severe pain in his replaced left hip. Tests for metal ions revealed he had elevated cobalt and chromium levels.

In October 2016, Mark endured a left hip revision surgery. His surgeon confirmed that the “hip implant failure was due to mechanically assisted crevice corrosion at the juncture between the LFIT V40 Head and Accolade TMZF Plus Stem.”

The LFIT V40 head is made of cobalt and chromium. The Accolade stem is made of a titanium alloy. The combination of these different metals reportedly leads to fretting and corrosion due to the friction placed upon them when the patient’s hip joint moves.

According to the Stryker LFIT CoCr V40 head lawsuit, researchers knew of significant corrosion between these dissimilar metals as far back as the 1980s.

Still, Stryker insisted in its marketing materials that its hip system included a metal stem and metal head that were made of proprietary alloys that would resist fretting and corrosion.

In January 2009, Stryker issued a voluntary recall of certain sizes of the Accolade TMZF Plus femoral stems because of a “lack of tensile bone strength and crystallinity.”

In August 2016, Stryker issued a voluntary recall of some lots of its LFIT V40 heads made before 2011 because of a “higher than expected” incidence of taper lock failure.

The Stryker LFIT CoCr V40 heads generated metal debris that induced an “inflammatory response” and “adverse local tissue reaction” in some patients who needed additional surgery to revise or replace the problematic component.

Stryker LFIT CoCr V40 Heads Cause Metallic Reactions

The Stryker LFIT CoCr V40 lawsuit alleges the company knew of the problems with the metal hip system, but continued to market the product. Among the issues that have been reported with a Stryker LFIT CoCr V40 are:

• Metal poisoning in the blood
• Pseudotumor formation
• Tissue death
• Fatigue
• Weakness
• Cognitive dysfunction
• Vertigo
• Visual and hearing impairment
• Cardiac complications
• Hypothyroidism
• Neuropathy

The Stryker LFIT CoCr V40 lawsuit contends that Howmedica “failed to recognize the defects in the Stryker Hip System due to poor and inadequate assurance procedures, including the failure of Howmedica to implement appropriate physical, manual, x-ray, microscopic and other inspections of the Stryker Hip System.”

The company allegedly knew the device was “unreasonably dangerous” to patients and failed to ensure the Stryker LFIT CoCr V40 head and the Accolade TMZF Plus stem worked together safely and properly after implantation.

The Stryker LFIT CoCr V40 Lawsuit is Case No. 2:17-cv-00440-JAW in the U.S. District Court for the District of Maine.