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Research has called attention to the potential for the Stryker Tritanium Acetabular Shell to loosen. In some cases, patients have had to undergo revision surgery to correct the situation. (1) (2)
Some orthopedic researchers are recommending doctors should monitor closely all their patients for cup loosening or patient symptoms if they have received a Stryker Tritanium Acetabular Shell as part of their hip replacement procedure. (3)
Research suggests the coating on the Tritanium shell components, known as “Particle Sintered Foam,” used in this hip implant model may be failing to integrate adequately with the acetabular bone.
If you received a Stryker Tritanium Acetabular Shell and have experienced any of these complications with your hip replacement system, we invite you to contact Weitz & Luxenberg:
Despite these issues that patients are experiencing, no recall has been issued by the manufacturer or the U.S. Food and Drug Administration (FDA) for the Stryker Tritanium Acetabular Shell.
Even though neither the FDA nor the manufacturer have issued a recall, you may be able to pursue legal restitution for any pain and suffering or expenses you are facing as a result of these acetabular shells.
In addition to literature describing Tritanium acetabular cup loosening, adverse event reports describing acetabular loosening in patients with Tritanium acetabular cups exist in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. (4) (5) (6) (7) (8) (9)
In one study, more than a third of patients who had been implanted with a Tritanium acetabular shell showed signs of radiolucencies around the implant in the pelvis and sclerotic changes in the bone in the hip joint after just one year of having the implant. (10)
These results suggest that these patients, who were all implanted with a Tritanium Primary Acetabular Component, may display “evidence of clinical deterioration and component loosening” over time. These findings suggest the Stryker Tritanium cup is failing to achieve bony ingrowth with patients’ acetabulum (pelvic bone). (11)
Another study also involved patients who received the same cup. In this study, researchers identified five patients who had already undergone revision surgeries because of failed Stryker Tritanium acetabular shells. (12)
These patients needed to undergo revision surgery because of loosening of their hip component. These patients were especially notable for their acetabular implants specifically often being described as well-seated, with good fixation intraoperatively, but after several months the patients presented to their orthopedic surgeons with symptoms such as hip and groin pain, especially while walking or during activities. (13)
Even though these patients had received an implant that also made use of screws to further stabilize their hip implants, the implants failed to achieve bony ingrowth. The absence of bony ingrowth or gross looseness of the Tritanium primary acetabular cup was specifically noted in all of these patients by their orthopedic surgeons during revision surgery. These orthopedic surgeon researchers concluded their results “suggest a need to examine the safety” of these acetabular cups. (14)
Ellen Relkin will be happy to review your case.
Radiographs, or x-rays, are images produced as a result of how different tissues in the body absorb different levels of radiation. Bones, made of calcium, absorb a lot of radiation and therefore show up as fairly light images.
Soft tissue, such as fat, tendons, and ligaments, absorb less and therefore look darker. Because of this, bones are easy to see on x-rays and soft tissue is much more difficult to see.
Following a hip replacement procedure, implant components also show up very easily on radiographs. They are very light and bright, much brighter than bone.
Radiologists look for expected and normal areas of lightness and darkness, among many other features that can be seen on diagnostic imaging. Too much darkness (radiolucency) around the perimeter of a Tritanium Stryker acetabular cup (periprosthetic lucency) may mean the part of the implant that sits against your pelvic bone has failed to integrate appropriately.
Generally speaking, for loosening, “periprosthetic lucencies wider than 2 mm and/or progressive lucencies are signs of abnormality.” (15)
It is reasonable to expect a hip implant to last for approximately 15 to 20 years. (16)
If your Stryker Tritanium Acetabular Shell has loosened within just months or a few years of your initial hip replacement surgery, your hip implant may have failed prematurely.
Failure of your Tritanium Stryker acetabular shell may require revision surgery. But physicians do not simply schedule you for revision surgery right away.
You will likely need to undergo diagnostic imaging to determine the cause of the problems you are having, and confirm if they are due to loosening of your hip implant. Depending on the imaging needed, the costs potentially can be quite expensive.
Examination of patients prior to undergoing revision surgery is more extensive than an examination prior to a patient’s initial hip replacement surgery. Oftentimes, surgeons need to conduct a number of potentially costly diagnostic procedures, such as: (17)
Surgeons may order these to investigate the cause of a patient’s symptoms, such as hip pain or trouble walking. Orthopedic surgeons and radiologists can sometimes determine the cause of a patient’s problems, such as loosening, metallosis, infection, or other complications, based on what the imaging reveals. Surgeons are also often able to examine the position and fixation of the hip implant parts.
In addition, surgeons often can determine the extent of bone loss from this imaging. Orthopedic surgeons may also wish to collect a fluid sample by doing an aspiration, as well as arrange for special blood work, especially if they suspect an infection is occurring.
Revision surgeries have more potential for complexity and complications than initial hip replacement surgeries. (18)
For example, when parts of an implant are attached to bone, some bone loss usually happens. You may also lose additional musculature around your hip during a revision surgery.
This means you may lose some strength in your hip joint. This loss may pose greater challenges after revision surgery than your initial hip replacement surgery.
The success rate following a revision surgery is also harder to predict than that of an initial hip replacement procedure. Complications may occur more frequently. Overall, a revision hip replacement surgery is more challenging. (19)
Each time you undergo a revision surgery, you may lose more bone, more muscle, or both. Revision surgeries also generally take longer and patients face a greater possibility of complications than they did with an initial hip replacement procedure.
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Weitz & Luxenberg is now accepting cases from people who have received a Tritanium acetabular shell and have experienced loosening or implant failure due to loosening.
If you would like to know if you were implanted with a Stryker Tritanium Acetabular Shell, your orthopedic surgeon should be able to tell you.
If a Stryker Tritanium Acetabular Shell was used during your hip surgery and revision surgery due to acetabular cup loosening was necessary or has been recommended, you may be entitled to compensation.
An attorney specializing in defective medical devices can provide you with more information and guidance about your legal options.
W&L has dedicated itself to helping clients for more than 30 years. We are a national leader in representing clients across the country who have been harmed due to defective drugs and medical devices
We are prepared to help you. For a free initial consultation, we invite you to contact us at (800) 476-6070 or fill out the form on this page.
One of our client relations representatives will be in touch with you shortly. We can provide you with the legal guidance you need.