A manufacturer of medical equipment and orthopedic devices, Stryker Orthopaedics, has been under close scrutiny for their LFIT V40 Femoral Heads (used in hip replacement surgeries) ever since they began receiving frequent complaints of taper lock failures in the devices.
This is not new for the company, which has faced past controversy over other hip implant systems they manufacture and has made headlines for their recalls of faulty products, as well as resulting legal settlements.
Currently, Stryker is the subject of a variety of lawsuits alleging that the LFIT V40 femoral heads have not been properly designed and manufactured and that patients who have been given the LFIT V40 femoral heads during hip replacement surgeries have suffered from subsequent failures.
Recently Stryker paid a $1 billion settlement for their Rejuvenate device.
LFIT V40 Femoral Head
Used in hip replacement surgeries, the Stryker LFIT V40 femoral heads are one component of two that are implemented during the artificial replacement (the other component being femoral necks). Both the femoral heads and the femoral necks are made of metal, and the complaints Stryker has received concern the taper lock—a device that connects the femoral head to the femoral neck.
Healthcare professionals and patients worry that a reaction between the heads and necks is causing the metal in the components to corrode, sending metallic elements into the blood stream and creating the potential for metal poisoning (also referred to as metallosis).
LFIT V40 Failure Symptoms
If the taper lock fails on a Stryker LFIT V40, patients could be at risk for:
- Loss of mobility
- Adverse local tissue reaction
- Joint instability
- Broken bones around the components
- Leg length discrepancy
- Need for revision surgery
- Swelling and inflammation at the surgical site
- Discoloration of the tissue at the surgical site
Hip Replacement Surgeries
Hip replacements are becoming increasingly common in the United States. According to a report published by the U.S. National Center for Health Statistics (NCHS) on February 12, 2015, the number of hip replacement surgeries more than doubled from 2000 to 2010, jumping from 138,700 to a staggering 310,800.
The NCHS report also found that hip replacement surgeries are growing more popular with younger patients, discovering that hip replacement surgeries during that same time period increased 205% in individuals aged 45 to 54.
More hip replacement surgeries for younger patients will also mean more hip replacement surgeries in coming years, as the artificial hip implants wear out and have to be replaced by new components.
Hip Implant Recalls
While the Food and Drug Administration (FDA) has only issued three recalls of hip implants, hip implant recalls done voluntarily by their manufacturers are surprisingly frequent. From November 1, 2002, to July 23, 2013, there was a total of 578 hip implant recalls by the top makers of hip implants.
Of those, Stryker was responsible for the greatest number of recalls, recalling 231 of their hip implant devices (equivalent to 40 percent of all the recalls).
Stryker Hip Recall
Of the 231 Stryker hip implant replacement recalls in that time period, 178 were classified as Class 2 recalls by the FDA. Class 2 recalls are defined by the FDA as “a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The remainder of Stryker’s recalls were Class 3. No hip implant recalls in that period were classified as Class I (the FDA’s most serious and harmful ranking).
Perhaps the most well known Stryker recall was the 2012 combined recall of both the Rejuvenate and the ABG II modular-neck stems that the company manufactured. Stryker decided to issue the voluntary recall and terminate distribution of both products worldwide after accepting the risks of “fretting and corrosion at the modular neck junction.”
By the time of the recall, the FDA had received numerous reports of issues involving both modular neck-stems. After Stryker issued the Rejuvenate and ABG II recalls, a number of lawsuits were filed against the manufacturer for resulting harm from the faulty devices.
Official Warnings on LFIT V40 Femoral Heads
Though the FDA has not yet issued any warnings on the Stryker LFIT V40 femoral heads, specific ranges of the devices have been singled out by both the Canadian and Australian governments for their risks.
Many believe that Stryker is close to issuing a formal voluntary recall of the LFIT V40 femoral heads. This speculation is based on both the Canadian and Australian government warnings and on the fact that Stryker recently issued an “Urgent Medical Device Recall Notification” to healthcare professionals asking them to follow up with patients who received LFIT V40 femoral heads from certain lots.
This echoes the “Urgent Field Safety Notice” the company sent about the Rejuvenate and ABG II devices right before they voluntarily recalled both in 2012.
Health Canada Recalls LFIT V40
In response to the higher than expected number of complaints received regarding the device, Health Canada issued a recall of the LFIT V40 on August 24, 2016. In the LFIT recall notice, Health Canada stated that the complaints focused primarily on “specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011.”
Australia Issues Hazard Alert On LFIT V40
On September 27, 2016, the Australian Government Department of Health’s Therapeutic Goods Administration (TGA) issued a Hazard Alert on the potential taper lock failures of the Stryker LFIT V40 femoral heads. They did so after Stryker itself issued a hazard alert on the devices.
The TGA advised those who had received LFIT V40 femoral heads during surgery to contact their orthopedic surgeons if they were experiencing “unexpected pain, loss of mobility, inflammation, instability or other problems related to your implant.” At the same time, the TGA advised orthopedic surgeons to follow up with their patients who received the device, if possible.
Stryker Hip Lawsuit
In response to the more than 4,000 lawsuits filed against Stryker after their recalls of the Rejuvenate and ABG II modular neck-stems, Stryker would eventually settle. The settlement was announced in 2014, two years after the recalls, and later expanded in 2016.
Aside from the side effects experienced by patients who had the Rejuvenate and ABG II modular neck-stems implanted, it was also common for revision surgeries to be necessary—leading to further health complications and delaying healing.
Stryker LFIT V40 Lawsuit
Lawsuits have been filed against Stryker by patients who received the LFIT V40 femoral heads during hip replacement surgery and suffered from a failure of the devices.
The lawsuits allege that the LFIT V40 was defectively designed and manufactured and that Stryker has been negligent in warning patients about the risks of harm from the devices, including metallosis.
Stryker Hip Lawyer
If you or a loved one received a Stryker LFIT V40 femoral head during hip replacement surgery and faced resulting adverse effects, we invite you to contact Patterson Dahlberg to go over your rights and legal options.
Your consultation is no-fee, and we are happy to answer any questions you may have. During your consultation, we can also inform you of whether you may be eligible for legal compensation from any negative impact of the LFIT V40.