SAFETY ALERT – Stryker LFIT V40 Cobalt Chrome Femoral Head
Stryker announced a new voluntary recall involving certain femoral heads that are used in total hip replacement procedures. On August 29, 2016, Stryker sent an “Urgent Medical Device Recall Notification” letter to surgeons that have implanted or reported problems with certain Stryker LFIT V40 femoral heads made before 2011. The letter explained that Stryker has received a higher than expected number of complaints involving the recalled femoral heads and may cause hip replacement failure. Fill out our free case review or call us at 1.800.887.8029 and our team can help you determine if you have one of the problematic devices.
Stryker LFIT V40 Recall
The new Stryker LFIT V40 recall extends beyond the United States. On August 24, 2016, Health Canada, the Canadian public health agency, issued a recall notification to the general public, healthcare professionals and hospitals regarding certain models of the LFIT CoCr V40 femoral heads. Then, on September 27, 2016, the Australian Government Department of Health published a Hazard Alert regarding certain Stryker LFIT V40 femoral heads.
This is not the first time Stryker has initiated a recall of hip components with a higher than expected rate of failure. In 2012, Stryker also recalled its Rejuvenate and ABG II modular stems, that were linked to high early failure rates, resulting in some patients having to endure early revision surgery to replace their faulty hip replacement. Zimmerman Reed represented patients and families affected in this lawsuit which eventually led to a large settlement where Stryker has anticipated paying $1.4 billion to patients who had to undergo revision surgeries.
Stryker Hip Problems
The Stryker Recall Notification informs doctors that Stryker has received a higher than expected number of complaints for some of its LFIT Anatomic CoCr V40 femoral heads. Based on the information Stryker has received, Stryker notified surgeons of potential hazards and problems with the recalled devices, including:
- Disassociation of the femoral head from the hip stem
- Hip stem fractures
- Excessive metallic debris
- Insufficient range of motion
- Loss of implant/bone fixation strength
- Excessive wear debris
Stryker warned surgeons that the voluntarily recalled devices may cause loss of mobility, pain requiring revision surgery, adverse local tissue reactions, dislocations, joint instability and other complications. If you are experiencing, or have experienced problems that may be related to the new Stryker voluntary recall, contact our team today at 1.800.887.8029 – we can help you navigate the next steps.
Stryker Hip Failure Diagnosis and Treatment Options
Stryker’s Recall Notification does not give specific directions about follow-up treatments for patients implanted with the LFIT V40 femoral stems that are part of Stryker’s recall. However, someone who has a recalled Stryker hip may be able to tell if their device is failing by undergoing a blood test to check the person’s cobalt and chromium levels. Elevated cobalt and/or chromium levels may indicate that a person’s Stryker hip is defective because it is releasing metal ions at the junction between the LFIT V40 femoral head and the stem component. People with elevated metal ion levels may require a revision surgery to remove and replace the failed hip replacement system.
If you were implanted with a Stryker hip system, contact our office today to learn about the treatment options some of our other clients have received.
Stryker Recall of the Rejuvenate and ABG II Modular Hip Stems
Other Stryker hip replacement components have also been involved in recent recalls, such as the Rejuvenate and ABG II modular hip stems. In July of 2012, the FDA announced that Stryker had commenced a voluntary recall of the Rejuvenate and ABG II stems because of fretting, corrosion and device failure at the junction between the neck and stem. Based on Stryker’s recent Recall Notification about the LFIT V40 femoral heads, it appears some patients implanted with LFIT V40 heads are experiencing similar injuries as people who were implanted with the Rejuvenate and ABG II stems.
If you were implanted with a Stryker hip system, you may have been implanted with one of the devices that has been recalled. Our team is experienced in hip device litigation and we are ready to help you determine whether you were implanted with a recalled hip replacement system. Contact us at 1.800.887.8029.
Will I be notified if my hip replacement system is defective?
Doctors are ordinarily not required to notify patients that a medical device implanted in the patient has been recalled. Therefore, patients sometimes are not aware of new device problems that might impact their health, safety, and wellbeing. The Stryker LFIT V40 head is often implanted along with the following components:
- Stems: Rejuvenate, ABG II, Accolade, Secur-Fit, and Restoration
- Liners: X3
- Acetabular Cup: Trident
How We Can Help
Our team is standing by and ready to help you determine if any of your hip replacement components have been part of a recall, safety communication, or hazard alert. To learn more about the hip replacement you received, contact us at 1.800.887.8029. We welcome any questions you may have.