The Stryker V40 recall was initiated by the company the last week of August 2016. The LFIT V40 femoral head is part of a total hip arthroscopy (THA) prosthetic unit made of all metal and marketed as early as 2006.

The LFIT V40 femoral head was cleared for market through the Food and Drug Administration’s (FDA) 510(k) process. This is a process requiring less safety testing because it allows new medical devices to piggyback on similar devices already on the market that have had clinical trials and full prior-marketing safety protocols run on them.

The onus is on the manufacturer of the device with the 510(k) program to prove the new device is “substantially equivalent” to the device that’s already on the market.

The FDA announced the recall as a Class 2 Stryker V40 recall on Nov. 9, 2016. The problems that had shown up with this prosthetic device leading to this recall action were many.

Problems were reported with the device’s stem, the base that is implanted into the major bone of the upper leg. Several stems had reportedly come loose from the femoral head, some stems actually fractured, and corrosion at the juncture between stem and femoral head had often led to a build-up of metallic debris.

This metallic debris caused a host of its own difficulties including soft tissue damage and bone tissue loss, inflammation, and debilitating pain.

Some of the stems used with the Stryker V40 recall are the Accolade TMZF, Accolade 2, Meridian, and Citation.

The Stryker LFIT V40 femoral heads are made of cobalt and chromium. Many of the difficulties with this product seemed to arise when it was combined with stems made of titanium. This combination was an unknown setup for corrosive activity in the absence of significant safety testing.

Tests to Determine Hip Implant Failure

In addition to the telltale sign of severe pain and inflammation, this corrosive activity might be additionally revealed by a blood cobalt test. Cobalt is naturally present in the body, but excessive amounts can pinpoint other issues.

If not caught by a physician, leaching cobalt from a defective femoral head prosthetic unit can lead to additional medical problems over and above hip joint deterioration. Toxic amounts of blood cobalt have been implicated in brain and nerve damage, hypothyroidism, and diseases of the heart muscle.

Sometimes a failing hip implant will produce difficulty with walking but not necessarily with any pain. Also, at times, there may be little or no symptomology of prosthetic component issues until the hip reaches a ‘breaking point’ at which nothing but a complete revision and installation of a new prosthetic with all associated risks becomes necessary.

If you have concerns regarding this recall notice, see your physician and request an X-ray or MRI. These tests help diagnose any problems early.

The Stryker V40 Recall Parameters

The Stryker V40 recall affects femoral heads with the following diameters and offsets: 36mm plus 5mm offset; 40mm plus 4mm offset; 40mm plus 8mm offset; 40mm plus 12mm offset; 44mm plus 4mm offset; 44mm plus 8mm offset; and 44mm plus 12mm offset.

According to the FDA at the time of the recall, 42,519 units were in circulation domestically and internationally, with an unknown number of that figure implanted into patients.