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Minnesota Man Brings Claims Against Stryker After Hip Implant Failure

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A Minnesota couple has filed a new hip replacement lawsuit against the makers of the Stryker Accolade TMZF hip stem and LFIT Anatomic V40 femoral head. They filed their case on November 14, 2016, in the U.S. District Court for the District of Minnesota.

The couple claims that after the husband was implanted with the Stryker hip replacement system, he suffered serious side effects leading to hip implant failure and revision surgery. He and his wife seek in excess of $75,000 in damages.

Plaintiff Suffers Metallosis and Hip Implant Failure

According to his complaint, the plaintiff was implanted with the Stryker Accolade system using the LFIT V40 femoral head on July 19, 2007. Shortly after the surgery, he started to experience discomfort in the hip area. He also developed an audible “clunk” in the hip when he walked.

A thorough medical checkup revealed a gross failure in the Accolade “trunnion,” which is the part of the implant where the head and neck connect and where the ball that fits into the hip socket connects with the stem that fits into the thighbone. Doctors also found that the plaintiff had elevated levels of cobalt, chromium, and titanium ions in his blood, revealing the presence of “metallosis,” or metal poisoning.

As a result, the plaintiff’s surgeons recommended the device be surgically removed and replaced with a new one in a procedure known as “revision surgery.” This surgery is more complicated than the original surgery, and often requires a longer recovery period.

Once they got the allegedly defective device out of the plaintiff’s body, they found that the Stryker LFIT V40 femoral head had failed, causing gross deformation and permanent muscle and tissue damage. The plaintiffs bring counts of negligence, breach of warranties, failure to warn, and design and manufacturing defects.

Stryker Recalls Defective LFIT V40 Femoral Head

The Stryker LFIT V40 femoral head is a modular component used in many hip replacement systems, including the Accolade TMZF. It is made of cobalt and chromium and is designed to fit with the stem of the Accolade and other hip replacement devices.

The two components are designed to help doctors customize the hip replacement system to fit each unique patient, to assist with joint stability and restore the joint without lengthening the leg. The LFIT V40 comes in a number of different sizes and angles to accommodate a wider range of patient body types.

When Stryker released these components, they stated that laboratory testing confirmed that they were compatible and wouldn’t cause fretting or corrosion. On August 29, 2016, however, Stryker released an urgent medical device notification to orthopedic surgeons, recalling certain sizes of the LFIT Anatomic CoCr V40TM Femoral Heads, manufactured prior to 2011, because of a higher than expected number of complaints concerning fretting and corrosion.

The Accolade TMZF stem has also been linked with reports of fretting and metallosis. In 2012, Stryker recalled its Rejuvenate and ABG II modular hip systems, which used the same titanium metal in the femoral stem as that used in the original TMZF system. Stryker has since abandoned the use of this metal and the new Accolade II stem is manufactured from a different titanium alloy.

The plaintiff asserts that Stryker failed to use reasonable and due care for the safety and well-being of those in whom the device would be implanted, and more specifically, that they failed to ensure that when the components were combined, they would not fret, corrode, deteriorate and induce severe metal toxicity in patients.