Cobalt-Chromium Toxicity Resource Center

Stryker LFIT V40 Hip Recall


On September 27, 2016, Stryker Orthopaedics, and the Therapeutic Goods Administration (TGA), Australia’s equivalent of the Food and Drug Administration (FDA), issued a hazard alert for LFIT Anatomic CoCr V40 femoral heads used in hip replacements. Although the FDA has not yet issued an alert, individuals with this hip should be concerned.

The concerns with these hips is that there is a problem with the juncture where the head of the hip (also known as the ball) meets the stem.  This is called the “taper lock juncture.”  There is concern that the juncture was not designed properly and, as a result, the two pieces of dissimilar metal rub against each other.  This causes corrosion and the release of cobalt and chromium ions into the hip joint.

Although the LFIT CoCr V40 is not a “metal on metal hip”, the release of cobalt and chromium ions can cause symptoms similar to those experienced by people with these hips. Here is a case study series by the Mayo Clinic discussing trunnionosis secondary to the taper lock failures: Trunnion Corrosion Causing Failure in Metal-on-Polyethylene Total Hip Arthroplasty with Monolithic Femoral Components, April 2016.

According to the FDA’s website:

“There are some case reports of the metal particles causing a reaction around the joint, leading to deterioration of the tissue around the joint, loosening of the implant and failure of the device . . . . In addition, some metal ions from the implant may enter into the bloodstream. There have been a few recent case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart and thyroid gland.”

Stryker Orthopaedics, the manufacturers of the device, are well known for their recalled Rejuvenate and ABG II hips. Unfortunately, a range of the LFIT Anatomic CoCr V40 femoral heads, specifically those manufactured before 2011, have a significant risk of taper lock failures. The taper lock connects the femoral head to the femoral neck.

Side effects of taper lock failures include:

  • loss of mobility
  • pain
  • inflammation
  • adverse local tissue reaction
  • dislocation
  • joint instability
  • broken bones around the components
  • leg length discrepancy
  • need for revision surgery

Stryker identified the affected products. The item numbers, head diameters and offsets are listed below:

Stryker Hip Patients

If you or a loved one has a LFIT Anatomic CoCr V40 femoral head, you should contact your implanting orthopedic surgeon. If you are experiencing unexpected pain, loss of mobility, inflammation, instability or other hip related problems, contact your surgeon as soon as possible.

In most cases, your surgeon will order a “serum cobalt/chromium” blood test.  This test measures the amount of cobalt and chromium in your blood.  If your levels are elevated, this is a sign that your hip is failing.

Cobalt and chromium is measured in “parts per billion” or ppb.  Normal cobalt and chromium are at levels less than 1 ppb.  Many people with LFIT V40 heads have been found to have cobalt and chromium many times higher than normal in their blood.

If you have elevated cobalt and chromium in your blood, your surgeon will likely order what is called a Metal Artifact Reduction Sequence (MARS) MRI.  This is a special type of MRI that is designed to determine whether there is soft tissue damage in your hip or the development of pseudotumors (abnormal pockets of fluid).  These soft tissue injuries will not show up on x-rays.

How to find out whether I have an affected hip.

You can determine whether you have the affected implant by obtaining your “operative report.” An operative report is a written report that describes in detail what your surgeon did, and observed, during your hip operation. Most of the time, the operative report will list the make and model of the prosthetic hip used in your surgery.

If the operative report does not adequately describe the type of hip prosthesis, look for the “product ID stickers.” Whenever a hip prosthesis is used in surgery, each component of the hip comes in a box with a detachable sticker affixed to it. The sticker has a bar code and identifies the make, model, and serial number for the enclosed parts. Many surgeons detach the stickers from the box and then simply attach them to a piece of paper that is inserted into the patient’s medical records. The document with the product ID stickers will tell you exactly what type of hip was inserted into your body.

If you underwent revision surgery because your Stryker hip replacement failed, you may be entitled to compensation.

Metal Hip Implant Lawyers | Cobalt Chromium Toxicity 

Do you have an advocate looking out for your best interest?  At Kershaw, Cook & Talley, we represent hundreds of hip replacement patients who, for decades, continue to rely on our knowledge and expertise in fighting and winning cases against manufacturers that put defective medical devices on the market. All it takes is 3 simple steps! Start by sharing your story with us through our free evaluation form on this page or give us a call at 916-520-6639 for a free case evaluation.

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