One of the biggest names in the orthopedic surgery industry, Stryker Corporation makes as many headlines for massive recalls as they do for developing new technology. They famously recalled their Rejuvenate and ABG II modular hip stems in 2012, and two years later, settled a Stryker lawsuit over the devices for what’s estimated to be a more than $1 billion payout. The legal challenges Stryker faced over the hip implant complications from their devices, however, are far from over.
What Caused The Stryker Hip Implant Recalls?
Hip implant recalls are widespread in the fast-growing hip implant industry, and the Safe Patient Project found that from November 1, 2002 to July 23, 2013, the top manufacturers of hip implant devices issued almost 600 voluntary recalls (a concerning 578 in total).
The Stryker Corporation is perhaps guiltier than any other hip implant device maker when it comes to recalls. In the time span measured by the Safe Patient Project, Stryker issued the largest number of voluntary recalls—40 percent of the recalls issued in total.
While the reasons for Stryker hip implant recalls varies, one of biggest issues the orthopedic manufacturer has faced is negative side effects from metal-on-metal implants.
As Stryker has worked to advance their hip implant technology, they’ve gravitated toward two-piece femoral stems. On these two-piece femoral stems, a metal stem and a metal neck are intended to be separate but moving together, sliding against one another when the patient walks or runs. Unfortunately, while this new technology offers some benefits, it also has its own unique risks.
When these devices fail—as was the case with the Rejuvenate and ABG II stems—the two metal components can grind together, breaking miniscule particles of the metals down and sending them into the nearby tissue. This can lead to severe side effects and even metallosis (metal poisoning) that can require revision surgery for the patient.
Symptoms of Hip Implant Side Effects
The FDA recommends that patients who received a metal-on-metal hip implant have routine follow-ups with their surgeon, even if they aren’t experiencing symptoms of hip implant failure.
They also advise that anyone who received such an implant pay careful attention for the following symptoms:
- Noise (popping, grinding, clicking or squeaking) in the hip
- Changes in ability to walk
Some other more general symptoms have also been identified in patients who have elevated metal ion levels from their metal hip implant grinding. These symptoms include:
- Skin rashes
- Neurological changes, such as difficulty hearing or seeing
- Psychological changes, like depression
- Thyroid dysfunction (weight gain, fatigue, neck discomfort)
Because patients may not immediately connect these symptoms with their metal-on-metal hip implant, the FDA advises that patients speak with their primary physician about their symptoms and make sure to mention that they have a metal-on-metal hip implant. Follow up visits with an orthopedic surgeon and metal ion testing may be necessary.
Because of the high failure rate of some Stryker hip implant devices, the company has been the subject of lawsuits. The largest, to date, concerned the Rejuvenate and ABG II devices and their subsequent recalls.
In June of 2008, the FDA determined, after about a month of review, that the Rejuvenate Modular Hip System did not require a premarket approval application and allowed Stryker to start selling the device. A year later, in November of 2009, the FDA made a similar decision with the ABG II Modular Hip System and it entered the market alongside the Rejuvenate.
Three years later, after numerous complaints from healthcare professionals and patients, Stryker issued an “Urgent Field Safety Notice” regarding the two hip stems. Stryker sent the notice in April of 2012, and warned that the devices may lead to “excessive metal debris” and a possible need for revision surgery. Two months after, on July 6, 2012, the company finally recalled both the Rejuvenate and ABG II devices, but patients who received either hip stem begin to file lawsuits over the negative effects from their surgeries.
By 2014, Stryker reached a global settlement over the class action lawsuit concerning the two devices, and agreed to compensate patients who had needed revision surgery after using either the Rejuvenate or ABG II hip stem. The massive settlement is expected to surpass $1 billion and additional patients who needed revision surgery from 2014 to 2016 were recently added to the agreement.
Since settling their lawsuit over the Rejuvenate and ABG II devices, Stryker has continued to manufacture metal-on-metal hip implants, and has, once again, been the subject of safety concerns.
Most recently, Stryker has been scrutinized for their LFIT V40 femoral heads, a component used alongside a variety of Stryker’s hip stems, including the Accolade 2, Citation and Meridian stems. Like the Rejuvenate and ABG II, the LFIT V40 failure symptoms include metallosis and spontaneous dislocation, but much of the concern over the device has centered on high rates of taper lock failure (the taper locks connects the femoral neck to the femoral head).
Days after Health Canada issued a recall for the LFIT V40 femoral heads, Stryker sent out a familiar “Urgent Medical Device Recall Notification” on August 29, 2016. In the notification, Stryker asked orthopedic surgeons to follow up with their patients who had hip implant surgery using the LFIT V40 and warned that metallosis was a risk.
Since then LFIT V40 lawsuits have been filed against the company by patients who allege they designed and manufactured a faulty product and did not appropriately warn patients of the risks of the device.
Finding a Stryker Hip Implant Lawyer
If you or a loved one received a hip implant that utilized either the Rejuvenate, ABG II or LFIT V40, you may be entitled to financial compensation. The attorneys at Cutter Law can guide you through your options in a free case review, and can be contacted toll-free by calling 855-475-4383 or using the online contact form.