Metal On Metal Hip Implants Lawsuit. Doctors usually discuss with a patient what type of hip implant will be implanted prior to the procedure. However, if you don’t know what kind of hip implant you have, you should contact your doctor or orthopedic surgeon’s office; they should be able to provide you with this information.
You can also contact the hospital where you had the procedure performed and ask for a copy of the operative report as well as the implant chart stickers from your surgery.
Since the August 2010 DePuy ASR hip recall, metal-on-metal hip implants have been a major safety concern among the medical community and, to some extent, the public at large.
In 2011, the U.S. Food and Drug Administration (FDA) began evaluating every all-metal hip implant on the market over concerns that this variety of implant can shed tiny metal particles that can be absorbed into the patient’s blood, soft tissue and organs, which can then develop into major complications, many seriously painful, including pseudotumor formations, metallosis, and early implant failure, which requires a follow-up procedure to remove and replace the device; this procedure is known as revision surgery.
What symptoms should I look for?
You should be especially aware of any hip/groin pain, local swelling, numbness, or changes in your ability to walk. A patient with a metal-on-metal hip implant may experience any of those symptoms for numerous reasons.
If you notice you are experiencing one or more of them, it is important that you contact your surgeon immediately so they can begin the process of determining the cause of the symptom(s).
In January 2013 the FDA issued an alert that advises patients implanted with an all-metal hip replacement system who experience any of several symptoms (including pain, swelling, a change in their ability to walk, and/or a clicking sound emitting from the hip joint more than three months after surgery) to contact their doctor for evaluation as soon as possible.
The FDA also recommended blood tests for symptomatic all-metal hip implant recipients in order to check for elevated metal ion levels.
The agency noted: “Patients with metal-on-metal hip implants who develop any symptoms or physical findings that indicate their device may not be functioning properly should be considered for metal ion testing.”
The FDA also advises patients without symptoms of implant failure to undergo physical examinations and routine radiographs every one to two years.
Joint Surgery on May 15, 2013 found that magnetic resonance imaging (MRI) can be used to identify complications
Research published in the Journal of Bone & Joint Surgery on May 15, 2013 found that magnetic resonance imaging (MRI) can be used to identify complications occurring in patients with metal-on-metal hip implants even before they have any symptoms of failure.
So, one way to actively manage your condition as related to your hip implant would be to speak to your doctor about undergoing an MRI; your doctor can give you advice on how to approach this process.
A surgeon would recommend revision surgery (again, the surgical procedure to remove and replace an implant) once he deems it the suitable solution to a problem. As for when revision surgery is the solution, there are many potential reasons, including infection, dislocation, loosening of the device, and device fracture.
Your surgeon might also consider revision surgery based on whether you develop evidence of local or systemic reactions to the metal from your hip implant. In general, a surgeon will consider several factors before recommending whether revision surgery is advisable.
What are the risks of revision surgery?
Revision surgery can be a “complex and challenging procedure,” according to the American Academy of Orthopaedic Surgeons. Such a surgical intervention involves several potentially challenging considerations.
All revision surgeries related to hip implants require the surgeon to make an assessment of the patient’s existing bone quality. Other factors the surgeon needs to consider are: the impact of removal of the failed components, the ability to reconstruct remaining bone and soft-tissue structures; and the challenges of attaching new components to the bone.
Due consideration must be given to each of these challenges in order to perform a successful revision surgery.
Hip revision surgery must address both the femoral (stem and ball) components, as well as the acetabular (socket) portion.
- The hip bones may suffer from deficiencies due to loosening, fracture, or shielding of the bone from normal stress. These deficiencies are graded based on several classification methods.
- Once this assessment is performed, the surgeon selects the best method to remove the existing components. If parts of the implant still function, the surgeon may decide to try to retain them. Specialized removal techniques have been developed, including surgically splitting the femur bone to remove the cement and implants. Power and hand instruments capable of accurately cutting around the prosthesis are also now available.
- Once the failed components are removed, the remaining bone may require a complex reconstruction that requires larger or longer implants; bone grafting using ground up bone or large segments of bone; and possibly cement and metal cages.
- Finally, the selected revision hip implant must be firmly fixed to the bone, either with bone growing into small pores in the outer layer of the implant or by cementing the implant in place.
The list includes, but not is not limited to, the following products:
Smith & Nephew R3 Metal Liners for the R3 Acetabular System
Nephew Orthopaedics initiated a market withdrawal for metal liners for the R3 acetabular system
On June 1, 2012, Smith & Nephew Orthopaedics initiated a market withdrawal for metal liners for the R3 acetabular system. This was due to the higher-than-expected number of revision surgeries associated with the use of the device in total hip replacements outside the U.S.
In the U.S.:
- The R3 metal liner is only approved for use with the Birmingham Hip Resurfacing System.
- The R3 Acetabular System, a total hip replacement system component, is not cleared for use with the R3 metal liner.
DePuy ASR XL Acetabular System
On Aug. 24, 2010, there was a voluntary recall of the DePuy ASR total hip system because of new, unpublished data from the UK joint registry that revealed revision rates within 5 years were approximately 13 percent.
Note: UK joint registry data is indicative of revision rates only in the UK and may not necessarily directly correlate to revision rates in the U.S.
Zimmer Durom Acetabular Component
On July 22, 2008, a voluntary recall was issued for the Zimmer Durom Acetabular Component (“Durom Cup”); this was due to inadequate instructions for use/surgical technique.
If you are suffering from side effects related to your metal-on-metal hip implant, your first step is to obtain medical attention. If you are among the thousands of patients suffering from the side effects associated with metal hip implants, we would be pleased to discuss a potential claim with you.
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