Stryker Hip Lawsuit Faults Timing of LFIT V-40 Femoral Head Recall

Published on November 16, 2016 by Sandy Liebhard

A new hip replacement lawsuit claims that a recent recall for Stryker LFIT V-40 Femoral Heads should have been announced much earlier, and accuses Stryker of downplaying the hazards associated with the chromium-cobalt components. The complaint, which was filed on November 8^th in the U.S. District Court, District of Massachusetts, was brought on behalf of a Plaintiff who was forced to undergo revision surgery just six years after he received a Stryker Accolade TMZF Hip Stem in conjunction with an LFit V40 Femoral Head.

Stryker Hip Recall

In August, Stryker issued an “Urgent Medical Device Product Field Action Notification”  to announce a recall for certain large-diameter LFIT V-40 Femoral Heads in the U.S., Australia and Canada. The affected devices were manufactured before 2011, and had been associated with reports of taper lock failure. The notification also followed an August 2016 report in the Journal of Bone and Joint Surgery detailing five cases of catastrophic failure with Accolade/LFit V40 combinations. In each case, extensive corrosion of the components had caused the stem to fracture at the stem/head juncture.

Stryker has warned that taper lock failure may result in:

• Disassociation of femoral head from hip stem
• Fractured hip stem trunnion
• Excessive metallic debris
• Insufficient range of motion
• Insufficient soft tissue tension
• Noise
• Loss of implant: bone fixation strength
• Excessive wear debris (polymeric)
• Implant construct with a shortened neck length

Stryker Lawsuit Allegations

According to this most recent Stryker hip lawsuit, the Plaintiff received his Accolade TMZF Hip Stem with an LFit V40 Femoral Head in December 2009, and soon began to experience discomfort. Subsequent medical tests revealed high levels of metal ions in his blood. The Plaintiff was forced to undergo hip revision surgery in September 2015 due to the complications he experienced.

“[P]roblems with the V40 head/Accolade Stem combinations are much larger than those referenced in the Stryker Defendants’ recall notice and are caused by the metallurgical formula used to manufacture TMZF Accolade Stem and/or the geometry of the Cobalt/Chromium V4 Head,”  the complaint states.” “Plaintiff alleges that all V40 heads sold by defendants are defective and should be recalled. Instead, the Stryker Defendants have intentionally downplayed the risk of harm and limited the scope of its recall in an effort to hide from surgeons, patients and the FDA the true extent of problems with their defective hips.”