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On August 19, 2016, Stryker Orthopedics issued a recall letter concerning the LFIT V40 femoral head noting that the company had received a higher than normal number of product failures.  Since the medical device was manufactured between 2001 and 2011, none of the devices were removed from shelves because they had already been implanted or expired.

On May 22, 2018, Stryker expanded its safety notification by including 8 additional products to be recalled.  The expanded safety notification stems from a higher than expected number of complaints of femoral head/hip stem dissociation.

Since 2016, the LFIT femoral head has had problems associated with fitting the hip stem causing pain associated with device loosening, dislocation, peri-prosthetic fracture, leg length discrepancy, inflammation, and pain requiring revision surgery.

Stryker developed the two-part hip replacement system in order to give orthopedic surgeons the ability to tailor the devices to the individual patient.  However, as in this case, the two devices do not fit together properly causing serious adverse effects for the hip patient.

The V40 femoral head is used with several different types of Stryker stems including the Accolade stem. There are already lawsuits pending including one I filed involving the Accolade stem. This stem appears to be too small to properly secure the head. The case that I am litigating and others that I am familiar with involving the Accolade are brought by injured people suffering from metallosis leached from the defective joints between the metal stem and the head of the hip implant. Where there is micromotion between the stem and the head, the metal becomes scratched from the movement and corrosion takes place. This corrosion allows metal particles to leach into the hip compartment. These metal particles cause a condition called metallosis where the positively charged metal ions damage the tissue in the hip compartment. The tissue damage progresses to necrosis or death of the tissue and causes pain and inflammation. Frequently, MRI films will show fluid in the joint. Blood tests are usually ordered to check for high chromium or cobalt levels. Once the metallosis  process starts the only cure is surgery to redo the hip. These surgeries are called revision surgeries.

The V40 heads were used in the following Stryker products:Accolade TMZF, Hfx, Citation, LASST, Accolade II, Anato, Secur-Fit Advanced, and LSP76.

If you or a loved one have suffered pain, discomfort, or a lack of mobility after a Stryker implantation, please call Attorney Joe Saunders for a consultation.

Expanded Product Safety Notification

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