Shaw Cowart LLP has been involved in this litigation for a number of years and has successfully pursued claims against multiple hip manufacturers. If you or a loved one has had problems with a Stryker, or any other type of metal on metal hip, please do not hesitate to contact Shaw Cowart LLP for a free consultation to help protect your interests in this regard.
Stryker Warning Letter
Stryker Corp. is warning orthopedic surgeons that it has received a higher-then-expected number of reports involving hip failures associated with implants containing a specific femoral head manufactured prior to 2011, raising concerns about thousands of artificial hip implanted in recent years.
In an urgent medical device product field action notification (PDF) sent to health care professionals worldwide on August 29, the orthopedic device manufacturer warns of “potential hazards” associated with its LFIT Anatomic CoCr V40 Femoral Heads.
In this specific instance, Stryker notes problems where the femoral head connects to the femoral neck, known as a taper lock failure. This can lead to a total hip implant failure, causing extreme pain, problems walking, and requiring revision surgery.
“Stryker has received higher than expected complaints of taper lock failure for specific lots of the following certain sizes of LFIT Anatomic CoCr V40TM Femoral Heads manufactured prior to 2011,” the letter states, providing a listing of catalog numbers, head diameters and offsets for affected components.
While the action has not been specifically labeled a Stryker hip recall, such a letter may end up classified that way by the FDA, as healthcare providers are being told to check their inventory and “quarantine all subject devices pending return to Stryker.”
Doctors are being urged to be on the look out for problems where the femoral head may lose its secure connection with the hip stem, fracture, release excessive metal debris or cause symptoms such as:
- Pain, discomfort or annoyance
- Loss of mobility
- Adverse local tissue reaction
- Joint instability
- Periprosthetic fracture
- Leg length discrepancy
- High levels of cobalt/chromium in the blood
- Other problems requiring hip revision surgery
Since the connection between the ball and the socket works to mimic the motion of a natural human hip joint, the rubbing that causes metal particles to corrode or “fret” into the body can occur whenever the joint is being used like a natural hip joint – for instance, when a person walks, moves from a standing or sitting position, or does any other activity that causes movement of the hip joint.
So far, lawsuits concerning these Stryker hip replacement parts or systems have raised a number of problems and concerns. One is the risk of metal particles entering the body, which can cause pain, swelling, difficulty of movement, and even metal toxicity. A patient with a metal sensitivity also faces a higher risk of an allergic reaction. Often, additional surgeries are needed to address pain, tissue and bone death surrounding the hip replacement or bone loss. Problems like this were also listed in Stryker’s notice to doctors and hospitals.
The problems with these metal on metal hip replacements may go further than those listed in Stryker’s notice. For instance, some studies have found a potential link between the metal particles and heart problems, lymph node damage, or even cognitive problems. The Food and Drug Administration (FDA) has reported hundreds of complaints it received concerning the Stryker hip replacements, and patients who have one of these systems must continue to monitor symptoms carefully.
Shaw Cowart LLP believes it important to bring these issues to light, as it is unclear whether consumers who received the femoral heads will be notified directly that they may have a recalled hip replacement component.
Beginning in 2014, a number of lawsuits have been filed in U.S. courts indicating that users have experienced Stryker LFIT V40 femoral head problems, alleging that the components were defectively designed and manufactured.
More than Stryker
While the Stryker hips are the ones in the news the most right now, Shaw Cowart believes that several other metal on metal hip implants may be dangerous as well. Other potentially problematic hips include:
- Zimmer Kinectiv M/L Taper
- Zimmer Durom
- Wright Conserve
- DePuy ASR or Pinnacle
- Biomet M2A or Magnum
For insights into how to obtain fair compensation for damages that you or a loved one suffered as a result of defective hip replacement technology, call or email our team to schedule a free, private case evaluation.