Stryker LFIT V40 Femoral Head for Hip Implants

The use of Stryker Orthopaedic's LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral head for hip implants has been linked to serious complications, including the release of dangerous amounts of metal debris into surrounding tissue and catastrophic implant failure.  These complications can lead to extensive injuries including damage to bone, muscle, and nerves, which often require hospitalization and additional surgeries to replace the original device.   

What Is The LFIT V40 Femoral Head? 

The LFIT V40 femoral head is a component of Stryker's artificial hip implants used to replace a patient’s diseased hip joint. The LFIT V40 femoral head is often implanted along with Trident Acetabular Cups and the following femoral stems, also manufactured by Stryker: 

• Rejuvenate
• ABG II
• Accolade
• Secur-Fit
• Restoration

A patient implanted with a Stryker hip implant between 2006 and 2016 has a high likelihood of having been implanted with the LFIT V40 femoral head. 

The LFIT V40 femoral head was available in several different sizes to allow surgeons to better custom-fit the implant to the patient. It was manufactured by Stryker, and it was cleared for use by the FDA in 2001.  The LFIT V40 femoral head has been implanted in tens of thousands of patients since that time. 

FDA Clearance and Recalls

The FDA cleared the use of the LFIT V40 femoral head for total hip replacement.  When it was first introduced to the market, the LFIT V40 femoral head was touted by Stryker for its durability and for allowing an increased range of motion.  These attributes made it more appealing to surgeons, as these devices had the potential to accommodate younger, more active patients.

In August 2016, Stryker voluntarily recalled certain lots of the LFIT V40 femoral head manufactured prior to March 2011 due to increasing reports of device failure and patient injuries.  Many reports cited so-called “taper lock failure.”  The taper lock is the part of the hip implant that connects the femoral head to the femoral neck.  These complications can result from corrosion, which is likely to occur when the LFIT V40 is paired with femoral stems made from alloys other than cobalt and chromium.  The corrosion eventually leads to failure of the implant or other health consequences necessitating complete removal and replacement of the hip implant.

Stryker's recall was designated a Class II medical device recall by the FDA.  This designation indicates “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.”  On May 22, 2018 recall of the LFIT V40 was expanded to include all heads sized 36mm and greater that had been manufactured before 2011.

Thousands of patients have experienced adverse health consequences from the LFIT V40 femoral head, including: 

• damage to bone and tissue surrounding the implant
• nerve damage
• implant dislocation
• implant corrosion
• implant failure
• metallosis (buildup of metal in tissue and blood stream) 

These are serious complications, often requiring hospitalization and revision surgery to replace the original implant. In certain cases, the complications lead to crippling injuries, which a revision surgery cannot fix.  

Complications and Long-Term Risks 

Patients implanted with the Stryker LFIT V40 femoral head may be at risk of premature failure and/or dislocation.  Moreover, as the metal parts of this component corrode when paired with femoral stems made from alloys other than cobalt and chromium, they release metal particles, which create additional health hazards.  These complications may lead to severe and potentially crippling health problems, including bone, tissue, and nerve damage, as well as joint infection. 

At the time of the August 2016 recall, Stryker notified surgeons of potential hazards and problems with the recalled LFIT V40, including: 

• dis-association of the femoral head from the hip stem
• hip stem fracture
• implant dislocation
• decreased range of motion
• loss of implant/bone fixation
• metallosis
• damage to bone and tissue surrounding the implant
• insufficient soft tissue tension
• excessive polymeric wear debris
• loss of mobility
• periprosthetic fracture
• inflammation
• pain associated with implant loosening
• joint instability
• leg length discrepancy 

Lawsuits 

Thousands of lawsuits have been filed in the United States against Stryker and have been coordinated in the federal district court in Boston, Massachusetts and in Bergen County Superior Court, New Jersey.  In November 2018, Stryker announced a settlement to provide some plaintiff patients with compensation for complications and injuries they have suffered arising from the implantation of the LFIT V40 femoral head.

How We Can Help 

If you have suffered serious health problems after being implanted with a LFIT V40 femoral head, you may be entitled to reimbursement for medical expenses, lost wages, and other costs.

For a free consultation or more information about your legal options, please call the number below.