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Michael Phelan
Michael Phelan
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Stryker Hip Recall

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Why is the Stryker V40 femoral head subject to Recall and Hazard Alert?

Stryker LFIT Anatomic CoCr V40 femoral heads are modular components  used in total hip replacement surgeries.  This product is the subject of recall and hazard alert because some of the V40 femoral heads manufactured before 2011 have high failure rates due to taper lock failures.  The taper lock is the part of the metal device that connects the femoral head to the femoral neck.

1.  August 24, 2016 Canadian Recall of Stryker LFIT V40 femoral heads 

The Government of Canada recalled affected LFIT CoCr V40 femoral heads in a Type II medical device recall.

2.  On August 29, 2016 Stryker issued to surgeons an Urgent Medical Device Recall Notification of its LFIT Anatomic CoCr V40 Femoral Heads.

To date, there has not been a recall mandated by the FDA.

3.  September 27, 2016 Australian Hazard Alert regarding Stryker LFIT V40 femoral heads

On 9/27/16, the Australian Department of Health notified consumers and health professionals that Stryker Orthopaedics, in consultation with the Australian government, issed a hazard alert for a specific range of LFIT Anatomic CoCr V40 femoral heads.

Why is the Stryker V40 femoral head failing at high rates?

The V40 is one component of a taper lock system.  It can be difficult during surgery for hip implant surgeons to tell what size components will fit the patient.  The V40 femoral head is an interchangeable component available in multiple sizes.  Once the surgeon determines the appropriate size, the metal V40 is screwed onto a metal femoral neck where it acts as the end of the femur bone and is designed to move and rotate with the hip socket.

According to Australian authorities, “The increased incidence of taper lock failures relates to possible taper lock interface inconsistency.”  As the metal materials interface with one another, the components begin to corrode, leading to taper lock failure. Failure of the taper lock can result in complete loss of movement, severe pain, instability of the joint, bone, and dislocation of the hip.  Metal-on-metal hip implant failures due to the metal surfaces of components rubbing against one another lead to the Stryker Rejuvenate and Stryker ABG II recall where failure occurred in the stem-neck interface.

The problem with the V40 metal head is that there is friction between dissimilar metals – the  taper lock is comprised of titanium and the femoral head is comprised of chromium/cobalt.  This phenomenon can lead to galvanizing or run-away corrosion.

When metal-on-metal break down and corrosion occur, metallic shavings and ions get into the blood stream and can cause infection, tissue damage, pseudo tumors, metallosis, hip joint instability and pain, bone fracture, hip dislocation, and a host of other problems.  The result can be that the patient requires an invasive revision surgery to remove the defective hip implant parts.

For more information about the Stryker hip recall or your legal rights, please contact www.phelanpetty.com