Wednesday, December 21, 2011

December 2011, Conserve Hip Systems and possible failure?

In 2009, the FDA approved the Conserve Hip Systems, made and sold by Wright Medical Technology, Inc. 
Since 2009, there have been more than two hundred adverse reports where people claimed that the Conserve Hip Implant failed to do what it was promised to.  
At year end, there is now a pending Petition for an MDL regarding those cases. The issues relate to the Conserve Plus Total Hip Replacement System and the Conserve Plus Resurfacing System. The total replacement system has four parts--  a metal femoral stem, metal femoral head, metal modular neck and the metal Conserve cup. The resurfacing system has two components: the metal femoral head cap and the Conserve Plus metal acetabular cup. Both systems are intended to be used as a hip-replacement implant when a patient’s hip joints are damaged or diseased as a result of fractures, osteoarthritis, rheumatoid arthritis and avascular necrosis.
The common component in both systems—and what is at the heart of the lawsuits—is the “Conserve cup”, which is a cast cobalt chromium molybdenum piece that holds the metal femoral head, mimicking the natural movement of a hip joint. It is that unlined cobalt part that is allegedly causing serious harmful effects to patients who receive the implant device. The problem is that these two metal components cause the release of metal particles around the hip joint and surrounding tissue. As a result, a high percentage of patients have developed metallosis and biologic toxicity and are experiencing a high and early failure rate of the device.
Our office is investigating people who think this product failed after implant. 

From the FDA site:
CONSERVE® Plus Total Resurfacing Hip System - P030042
Picture of the CONSERVE® Plus Total Resurfacing Hip SystemThis is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
 Product Name: CONSERVE® Plus Total Resurfacing Hip System
PMA Applicant: 
Wright Medical Technology
5677 Airline Road, Arlington, Tennessee 38002
Approval Date:
 November 3, 2009
Approval Letter: 
 What is it? The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because only the surface of the ball (femoral head) is removed to implant the femoral head resurfacing component.
 How does it work? The CONSERVE® Plus Total Resurfacing Hip System has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).
  • The cup replaces the damaged surface of your hip socket (acetabulum).
  • The cap covers the ball-shaped bone at the top of your thigh (femoral head), and the cap has a small stem that is inserted into the top of your thighbone.
The cap moves within the cup. The surfaces that rub against each other (the bearing couple) are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.
 When is it used? The CONSERVE® Plus Total Resurfacing Hip System relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. Degenerative joint diseases include osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis.
The CONSERVE® Plus Total Resurfacing Hip System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
 What will it accomplish? The CONSERVE® Plus Total Resurfacing Hip System is intended to relieve pain and improve hip function.