The Stryker Corporation is a manufacturer of components for orthopedic surgery, with a focus on hip implant surgery. They are one of the largest hip implant makers, and many hip implant surgeries include components manufactured by Stryker.
Certain devices made by Stryker have been subject to complaints, recalls and even lawsuits. Arguably, the most notable of these were the ABG II and Rejuvenate Modular Hip Stems. Since then, Stryker LFIT V40 femoral heads—a component in many of Stryker’s hip systems—has made headlines for its tendency toward high failure rates and the company’s quiet recall of the product.
Understanding the Stryker LFIT V40
Modern hip implant technology often involves multiple components that make up the hip replacement, including the femoral stem, femoral neck, and, the femoral head. The Stryker LFIT V40 falls into the last category and is placed above the femoral neck and inside the hip socket.
Stryker uses LFIT V40 femoral heads in the following hip stems:
- Accolade TMZF
- Accolade 2
During a total hip replacement surgery, the LFIT V40 is fastened onto a femoral hip stem trunnion at the femoral neck through an element of the LFIT V40 known as a taper lock.
While Stryker claims the LFIT V40 femoral heads are more durable than other femoral heads on the market, most complaints about the hip implant device are focused on its high incidence of taper lock failure, specifically in LFIT V40 devices manufactured before 2011.
LFIT V40 Failure Symptoms
When the Stryker LFIT V40 taper lock fails, a variety of problems can occur. In some cases, the femoral head may even become dislocated from the stem, which can also contribute to metal debris being released into the nearby tissue and bone (a condition known as metallosis or metal poisoning).
A patient may become aware of a failing hip implant device, like the LFIT V40, through a variety of symptoms, some which are more closely linked to the device itself, and some which relate to metallosis.
Hip Implant Complication Symptoms
Patients who have undergone hip implant replacement should be alert for the following symptoms and should contact their orthopedic surgeon if they experience any of these symptoms or other similar symptoms:
- Reduced range of motion
- Loss of mobility
- Joint instability
- Pain at the location of the implant
- A slipping feeling in the hip joint
- Noise from the hip joint
Metal Poisoning Symptoms
Taper lock failure on the LFIT V40 can also cause metal poisoning when tiny particles of the metal that makes up the device are worn off and released into the surrounding areas, potentially damaging the bone and/or soft tissue nearby the implant and joint.
The symptoms of metallosis or “adverse reaction to metal debris” are more general, and patients may not link them to the hip implant. The Food and Drug Administration (FDA) advises monitoring for the following:
- General hypersensitivity reaction (skin rash)
- Neurological changes including sensory changes (auditory, or visual impairments)
- Psychological status change (including depression)
- Renal function impairment
- Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)
Stryker LFIT V40 Recalls
The high incidence of taper lock failure involving Stryker LFIT V40 femoral heads has led to recalls and warnings.
The first occurred internationally on August 24, 2016, when Health Canada recalled some lots and sizes of the LFIT V40 that had been manufactured before 2011. In justifying the recall, Health Canada said that they had received a “higher than expected number of complaints.”
Five days later, on August 29, 2016, Stryker quietly sent out an “Urgent Medical Device Recall Notification” to surgeons. The notification advised orthopedic surgeons to contact patients who’d had hip replacements utilizing the LFIT V40 femoral heads, and outlined some of the risks linked to the device.
A little less than a month later, on September 27, 2016, the Australian Government Department of Health’s Therapeutic Goods Administration (TGA) echoed Stryker’s recall notification by issuing a Hazard Alert. As with Stryker’s notification, the TGA suggested surgeons follow up with their patients and that patients watch carefully for the symptoms of hip implant failure.
On October 11, 2016, Stryker again sent out recall notification information on the LFIT V40 femoral heads, this time notifying healthcare professionals that additional patients and lot numbers had been identified.
LFIT V40 Lawsuits
Lawsuits have been filed against Stryker for their LFIT V40 femoral heads. The LFIT V40 lawsuits allege that the company holds blame both for the manufacturing and marketing of a faulty product, and for failing to warn patients of the health risks of the hip implant component, including the risk of metallosis.
Rejuvenate and ABG II Hip Implants
In 2008 and 2009, after minimal reviews, Stryker got FDA approval to market two modular hip stems: The Rejuvenate and the ABG II. In the three years that followed, both devices were the subject of some complaints to the FDA, and would eventually be recalled.
Problems with Rejuvenate and ABG II
While the complaints regarding the Rejuvenate and ABG II devices varied, most were linked to the same cause: fretting. Fretting occurs when the metal components of the device corrode or break off, carrying metal particles into the nearby tissue and bone, possibly leading to metallosis.
The fretting was occurring when components of the two modular hip stems would rub against each other while the device was in use—a flaw in the design. Problems caused by the Rejuvenate and ABG II were serious enough that many patients needed revision surgery.
Rejuvenate and ABG II Recalls
In April of 2012, the Stryker Corporation sent out an “Urgent Field Safety Notice” about the ABG II and Rejuvenate modular hip stems.
The notice mentioned that Stryker had received numerous reports of the ABG II and Rejuvenate hip stems failing, and of “excessive metal debris and/or ion generation.” At the same time, Stryker also acknowledged that the issues from the two devices could mean patients would need revision surgery.
The notice was followed, two months later, by a Rejuvenate and ABG II recall on July 6, 2016. The recall was a voluntary recall by Stryker and was not set by the FDA.
Rejuvenate and ABG II Lawsuits
Thousands of lawsuits were filed against Stryker regarding the Rejuvenate and ABG II modular hip stems. The lawsuits claimed that Stryker was aware of the problems with the two devices yet continued to both manufacture and market them.
The lawsuits were consolidated into a class action lawsuit, and, in November of 2014, a global settlement was reached. An estimated 3,000 patients who had either the Rejuvenate or ABG II hip stems implanted—and who later needed revision surgery—were compensated. Then, in December of 2016, Stryker expanded the settlement to include more patients who had needed revision surgery after being given the devices.
With no fixed fund specified in the settlement agreement, the Stryker Corporation is expected to ultimately pay more than $1 billion to customers who used the Rejuvenate and ABG II hip stems.
Other Stryker Recalls
Stryker has issued numerous voluntary recalls regarding their products. In fact, from 2002 to 2013, they issued the highest percentage of voluntary recalls of any hip implant manufacturer (40 percent of all the voluntary recalls issued in that time).
At various times, the Stryker Corporation has issued voluntary recalls of their Citation and Accolade hip stems for safety reasons. The almost 2,000 affected Citation hip stems were recalled because they did not meet Stryker’s testing requirements.
Do I Have a Case Against Stryker?
Patients who received the ABG II, Rejuvenate or LFIT V40 devices during hip implant surgery may be eligible to receive financial compensation for complications they sustained during their use of these devices. If you believe that you or a loved one received one of these Stryker hip implants, you can contact the attorneys at Cutter Law for a free case review by calling toll-free 855-475-4383 or by using the online contact form. Our extensive experience in hip implant litigation will help guide you through the best course of action.