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Wright Medical Revision Hip System

Wright Medical Group makes products such as the Conserve Hip System, Lineage and Dynasty devices and the Profemur Z. The FDA has issued recommendations to surgeons for the follow-up of patients with these device.

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WRIGHT MEDICAL HIP REPLACEMENT AND RESURFACING SYSTEMS

Wright Medical Group is an orthopedic company that specialized in joint replacement and resurfacing devices. In 2013, their OrthoRecon division was sold to MicroPort Orthopedics, Inc., who continued to manufacture the hip components.

Wright Medical Conserve

The Wright Medical Conserve Acetabular Hip and Wright Medical Conserve Hip Resurfacing Systems are part of a class of large-diameter, metal-on-metal (cobalt-chromium) monoblock hip resurfacing and replacement devices. The Conserve is a metal-on-metal hip, meaning that the femoral head and the acetabular cup lining are both made of a cobalt-chromium alloy, produced in different sizes to fit the needs of the particular patient.

Wright Medical Lineage and Dynasty

Wright Medical’s Lineage and Dynasty replacement devices are available in several variations that utilize a variety of femoral head and acetabular cup materials: ceramic-on-ceramic, metal-on-polyethylene, ceramic-on-metal, and metal-on-metal. The metal-on-metal versions are made out of cobalt and chromium.

Wright Medical Profemur Z

The modular Profemur Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology’s modular necks. The modular neck is the portion of the implant that fits onto the femoral stem so that the head can be attached to this portion of the implant that fits into the thigh bone (femur) to anchor the prosthesis.

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Health Complications

Procedures Performed During Cardiac Catherterization

Common safety issues associated with metal-on-metal hip systems include:

  • Local complications or Adverse Local Tissue Reactions (ALTR) such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions (ALVAL)

  • Early device failure and the need for revision surgery

  • Systemic complications from metal ion exposure.

Wright Medical Metal on Metal Hip Replacements are subject to similar complications as other metal-on-metal devices such as inadequate positioning, loosening, corrosion, fracture of the device, and dislocation.

There may be the potential for a local tissue reaction due to the presence of the foreign material alone. The clinical relevance of this reaction is not understood at this point. There exists a potential of debris forming over time along with elevated metal ions formed with the constant rubbing of the surfaces together.

Patients who continue to experience any of the following symptoms more than three months after their hip surgery may need to follow up with their surgeon to determine whether their device is working as intended.

  • Hip, leg or groin aches or pain
  • Joint swelling around one or both hips
  • An altered gait or ability to walk
  • Strange sounds such as clicking, grinding, popping or squeaking

Although some of these symptoms may be normal, it is possible they could require additional surgery. 1

FDA Action

Although there has been no recall of the Conserve, Lineage or Dynasty, with the exception of a recall of a host of units due to inaccuracies in labeling 2, the FDA and International regulatory agencies have issued recommendations to surgeons for follow-up of patients with metal-on-metal hip implants. 3

In addition, the FDA recently issued a recall of Profemur Neck Varus/Valgus CoCr 8 Degree modular neck devices manufactured from June 15, 2009 to July 22, 2015. Because MicroPort Orthopedics, Inc. did not acquire Wright Medical Group’s OrthoRecon business until 2013, some of these recalled devices were manufactured by Wright Medical.

The FDA records all adverse events of medical devices in the Manufacturer and User Facility Device Experience database or MAUDE 4. A simple search within the database for “PROFEMUR(R) and Z and STEM” (all years) returns multiple adverse event reports. Many of these records describe the event as removed “during revision” or “MoM complications” (MoM referring to metal on metal).

  1. U.S. Food and Drug Administration. Hip Implants. (Jan. 17, 2013). FDA.gov. Accessed Aug. 26, 2014. 

  2. U.S. Food and Drug Administration. Enforcement Report – Week of November 7, 2012. (Nov. 7, 2012). FDA.gov. Accessed Aug. 28, 2013. 

  3. U.S. Food and Drug Administration. Concerns about Metal-on-Metal Hip Implants. (Jan. 17, 2013). FDA.gov. Accessed Aug. 11, 2013. 

  4. U.S. Food and Drug Administration. MAUDE Database Search. (July 31, 2013). Aug. 28, 2013