A plaintiff from the state of Maine has joined other Stryker Hip cases in multidistrict litigation (MDL) currently before a U.S. District Court in Massachusetts. Plaintiff Gary H. is seeking compensation for injuries allegedly caused by a product manufactured by the defendant, Stryker Orthopaedics.

Case Background

Gary says he underwent total hip replacement for his right hip in late February of 2009, during which he was implanted with an LFIT Anatomic CoCr V40 Femoral Hip. He claims that defective design of the device caused serious personal injury, including metal toxicity due to “excessive levels of chromium and cobalt” in his blood.

Allegedly because of the device’s inherent defects, Gary says he was required to undergo revision surgery just over eight years later to have the hip implant removed, leading to his lawsuit.

In addition to manufacturing a device the defendant knew or should have known to be defective, Gary alleges negligence, failure to warn and breach of warranty as well as violation of Massachusetts’ consumer protection laws.

About the V40 Femoral Stem

According to the master complaint common to all Stryker hip cases in the MDL, the Stryker V40 femoral head features a unique tapered design not found in similar devices. Allegedly due to “poor design” and the materials used in joining the chrome cobalt head to the stem, the device was prone to corrosion and wear, releasing microscopic toxic metal shards into neighboring tissues and the bloodstream. This led to what physicians call “catastrophic dissociation,” which essentially means that the hip prosthesis falls apart. The V40 is the only such device in which this is known to occur, plaintiffs say.

The toxic metals released during deterioration of the Stryker hip V40 component can result in serious health consequences for the patient. Among these is a condition known as “Adverse Local Tissue Reaction.” This results from an immune system reaction in the presence of toxic metal, and can cause chronic pain and overall weakness. Another danger is tissue necrosis, or the literal death of living tissues.

The Stryker V40 femoral stem was subject to a Class II recall of the Stryker Hip by the Food and Drug Administration in August 2016.

Other Stryker Hip Cases

The V40 femoral head is not the first product for which Stryker has been named a defendant in injury litigation. In 2011, the Accolade TMZF Plus Hip Stem was recalled over an issue that was later attributed to an employee error. The following year, two more femoral stems, the Rejuvenate and ABG II were discovered to have similar defects, resulting in patients contracting metal poisoning. In 2016, the company agreed to a $1.4 billion settlement with plaintiffs in Stryker hip cases over the latter two products.

It is worth noting that the V40 was FDA-approved by way of the controversial 510(k) Premarket Notification Process. This is essentially a regulatory loophole that allows medical device manufacturers to bypass stringent (and costly) clinical testing and studies that are normally required before a medical device is allowed onto the market by demonstrating “substantial equivalence” to a previously-approved product.

Gary’s Stryker Hip lawsuit is part of MDL No. 17-md-2768-IT, filed in U.S. District Court for the District of Massachusetts.