Stryker ShapeMatch Lawsuit
Stryker Corporation has had trouble with their metal hip replacement systems in the past. They recalled two of them—the Rejuvenate Modular and AGB II Modular-Neck Hip Stems—in 2012, and subsequently faced hundreds of lawsuits filed by plaintiffs who had been implanted with the systems and then suffered serious complications like metal poisoning and premature implant failure.
Now it seems like history is repeating itself. On August 29, 2016, Stryker released an urgent medical device notification to orthopedic surgeons, recalling certain sizes of the LFIT Anatomic CoCr V40TM Femoral Heads, manufactured prior to 2011.
Stryker explained that they had received “higher than expected complaints of taper lock failure” for specific lots of the product, with potential hazards including disassociation of the femoral head from the hip stem, and excessive metallic debris.
Critics claim the recall has come too late. Many patients have already been injured—some experiencing catastrophic hip implant failure. None were properly warned of the risks. In fact, some plaintiffs have already filed lawsuits against the company, alleging that Stryker was negligent in failing to address the issues with the LFIT V40 years before they did.
What is the LFIT V40 Femoral Head?
The LFIT V40 Femoral Head is a component used in thousands of artificial hips. Hip replacement systems typically consist of several parts, including:
- Femoral head
- Femoral stem
- Femoral neck
- Acetabular shell or socket
The natural femoral head is the highest part of the thighbone (the femur), or the “ball” part of the ball-and-socket joint that is the hip joint. The femoral head is the ball that fits inside the socket of the pelvis bone and allows the hip to rotate back and forth.
In a hip replacement system, the acetabular cup replaces the socket, and the man-made femoral head replaces the natural femoral head, fitting inside the cup to allow rotation. The head is attached to the stem, which is driven into the femoral bone (thigh bone).
The Stryker LFIT Anatomic CoCr Femoral Heads are used with a number of hip implant femoral stems, including the following:
- Stryker Accolade TMZF
- Stryker Accolade 2
Stryker advertised the LFIT Anatomic CoCr Femoral Heads as being designed to minimize the risk of recurring dislocation while maximizing a patient’s hip movement and stability. They also stated that the technology reduced frictional forces, limiting wear and tear of the component. Subsequent reports, however, seemed to suggest that this technology has actually increased the risk of metal wear and tear, tissue damage, immobility, and hip implant failure.
Stryker LFIT V40 Femoral Head Increases Risks of Injuries
What’s gone wrong with the Stryker LFIT V40 component?
The most serious and concerning issue involves incidences where the femoral head actually disconnects from the femoral stem. One can think of the ball of the joint actually coming loose from the upper thighbone.
Recent medical research has found that in some cases, corrosion can occur at the head-neck juncture of the implant. Being made of cobalt and chromium, these materials can gradually wear away with time, poisoning the surrounding tissues, weakening the junction and sometimes, resulting in a complete connection failure.
In a 2014 study, for example, researchers noted that corrosion resulted in cases of pain, negative tissue reactions, pseudotumors (non-cancerous growths), and osteolysis (bone destruction) around the hip implant. The corrosion was also noted to be a potential cause of “spontaneous disassociation” of the femoral head from the stem.
In a 2015 study, researchers described “trunnionosis” (corrosion between the metal surfaces at the head-neck connection) as a potential factor in causing pseudotumors and related hip-implant problems. They added that “with at least one cobalt chromium component frequently present in hip arthroplasty prostheses, the incidence of this mode of adverse wear may be higher than previously thought….”
In a recent 2016 study, researchers described nine cases of total hip implant failure related to metal wear debris around the “trunnion” (connection between the femoral head and stem). Doctors found abnormal levels of cobalt and chromium in the patients, as well as tissue damage. They all had to go through revision surgery to fix the implant.
Finally, in a 2016 study review, researchers acknowledged that trunnionosis was “a growing cause of total hip arthroplasty failure.” In some studies, it’s been reported to cause up to 3 percent of all revisions, and it’s believed to be the result of modular junction wear, corrosion damage, and metal ion release.
Types of Stryker LFIT V40 Femoral Head Injuries
The potentially defective design of the Stryker LFIT V40 Femoral Head can increase the risk of the following injuries:
- Catastrophic hip implant failure
- Spontaneous disassociation of the femoral head from the stem
- Metal poisoning
- Tissue damage
- Osteolysis (bone damage)
Patients experiencing these dangerous changes in their hip implant may suffer the following symptoms:
- Pain (sometimes severe)
- Difficulty walking
- Elevated levels of cobalt and chromium in the blood
- Swelling and inflammation
If a spontaneous dislocation or “disassociation” of the head and the stem occurs, it can create an emergency medical situation, in which the patient requires immediate medical attention.
Treatments for these issues often involve an invasive revision surgery. Sometimes, if there has been a break at the head-neck junction, the doctor may have to remove the stem, which has usually grown into the thighbone at the time of surgery.
Stems are designed to encourage bone growth into the device, to stabilize the joint. Removing a stem, therefore, presents a number of unique challenges. These types of surgeries are difficult, and carry a risk of serious potential complications, including a fracture of the femur (thighbone). In rare cases, the femur has to be broken, the stem removed, and the femur put back together with wires and cables.
Meanwhile, the metal ions and fragments cannot be removed and may remain to cause additional pain and swelling.
Stryker LFIT V40 Femoral Head Recall
Health Canada announced a medical device recall of the Stryker LFIT CoCr V40 Femoral Head on August 24, 2016, noting that Stryker had received higher than expected complaints of failure with certain sizes manufactured prior to 2011.
Stryker released their “urgent medical device product field action notification” on August 29, 2016. This was a letter to orthopedic surgeons noting that the company had initiated a voluntary recall of certain LFIT Anatomic CoCr V40 Femoral Heads because of higher than expected complaints. Stryker asked that doctors quarantine any remaining devices, pending return to the company.
This action isn’t seen as an official recall in the U.S., but because Stryker is asking for the devices to be returned, it is often referred to as the Stryker LFIT recall. As of this writing, consumers have not yet been notified of an official recall for the component. Stryker has also not revealed the cause of the failures—whether it stems from a manufacturing or design defect, or both.
Australian health officials warned about the risks associated with the Stryker LFIT V40 Femoral Head on September 27, 2016. The Australian Therapeutic Goods Administration released a hazard alert warning consumers and health professionals that some components manufactured before 2011 had a “higher than expected incidence of taper lock failures.”
The “taper lock” is the part of the implant that connects the femoral head to the femoral neck. Officials warned that patients could suffer a loss of mobility, pain, inflammation, adverse local tissue reactions, dislocation, joint instability, broken bones, and leg length discrepancy should the failure occur. They advised consumers to be aware of these issues and to talk to their doctors about any symptoms, and also advised doctors to follow up on symptoms that could be related to this issue.
Stryker LFIT V40 Femoral Head Lawsuits
Patients who were implanted with a hip implant system including the Stryker LFIT V40 femoral head and then suffered serious side effects or injuries may be eligible to file a Stryker LFIT V40 femoral head lawsuit.
Patients may be unaware of which components were used in their hip replacement surgery. Chaffin Luhana provides consultations and case evaluations to help determine which components were used and whether patients may have a case against Stryker. It’s not always clear at first what may be causing hip pain and inflammation, but patients are going through these issues owe it to themselves to find out.
Call today at 1-888-480-1123.