!ALERT! Microport (Wright Medical) Profemur Hip Varus/Valgus Modular Neck (Part 1254) Recall



Recall of the MicroPort/Wright Medical Profemur Varus/Valgus Modular Neck

In June 2013, MicroPort Scientific Corporation, based in Arlington, Tennessee, entered into an agreement with Wright OrthoRecon to acquire Wright for $290 million. MicroPort was established in January 2014, quickly becoming the fourth largest multinational producer of orthopedic products.  Wright’s business is comprised of hip and knee implant devices, generating global revenues of up to $480 million annually, and controlling about 2 percent of the artificial hip and knee market worldwide.

 

Wright’s franchise brands include the Conserve hip, the Profemur modular stem, and the Advance and Evolution knee implants. Although Wright claimed its Conserve line of hip replacements would reduce wear and dislocation rates, the Conserve has demonstrated higher than normal failure rates. In fact, the FDA has received more than 200 adverse event reports related to the Conserve, and many liken it to the DePuy ASR hip debacle which resulted in a settlement which included more than 11,000 injured consumers.

 

Now, on the heels of mounting Conserve lawsuits, the FDA recently announced the MicroPort / Wright Medical Profemur Varus/Valgus Modular Neck Recall. The MicroPort/Wright Medical Profemur Varus/Valgus Modular Neck Recall is a Class I Medical device recall, potentially affecting as many as 10,825 consumers. A Class I recall is the most serious classification given to a medical device recall, meaning the implants have a reasonable probability of causing serious injury or death. Many reports of Profemur hip implant components fracturing suddenly after surgery have been received.

 

Such a sudden, unexpected fracture can lead to instability, mobility difficulties and extreme pain. The specific product recalled in the Microport/Wright Medical Profemur Varus/Valgus Modular Neck Recall is the Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. All lots are affected, manufactured from June 2009 to July 2015; sales of the modular neck continued after MicroPort acquired Wright, despite the fact Profemur lawsuits had already been filed.

 

MicroPort/Wright Medical Profemur Modular Neck Dangers

There are a number of MicroPort/Wright Profemur hip dangers with many patients experiencing unexpected MicroPort/Wright Medical Profemur hip fracture. Such an acute fracture can require revision surgery to remove and replace the neck and stem components. The patient can experience extreme pain and an immediate inability to walk, or even perform the most common task. Such an acute fracture can lead to MicroPort/Wright Medical Profemur hip neurovascular damage, MicroPort/Wright Medical Profemur hip hematoma, MicroPort/Wright Medical Profemur hip hemorrhage and even MicroPort/Wright Medical Profemur hip death. With respect to the recalled Profemur hip, there is no evidence a fracture can be anticipated through patient history, X-rays, CT scans, MRIs, physical exam or visual inspection.

 

MicroPort/Wright Medical Profemur Modular Neck Lawsuits

A 2012 court order transferred claims involving the Wright Profemur modular neck to an MDL, however only cases claiming injury from the metal-on-metal design or those in which a Profemur system was connected to a Conserve Total Hip or a Conserve Total A-Class Advanced were eligible to be a part of this particular MDL.  Other plaintiffs filed their own MicroPort/Wright Medical Profemur hip lawsuit through a federal or state court, outside of the MDL.  In November 2013, a MicroPort/Wright Medical Profemur hip lawsuit was settled for an undisclosed amount, just days before it was scheduled for trial. In this lawsuit against Wright, a Georgia man claimed he was implanted with a Profemur hip system in 2009, which subsequently broke as he was walking to work.

 

Timothy Courson underwent immediate revision surgery to remove the broken neck fragments, replacing the device with a safer one. Courson’s lawsuit alleged the MicroPort Profemur hip was responsible for his permanent injuries, including ongoing pain, injuries to the respiratory system and mental anguish. This particular hip settlement came in the same month as the DePuy Orthopedic ASR hip implant settlement for more than $2.5 billion.  Those who were injured by a MicroPort/Wright Medical Profemur Modular neck should consider speaking to a MicroPort/Wright Medical Profemur hip lawyer. Filing a MicroPort/Wright Medical Profemur hip lawsuit could enable those injured by the modular neck device to recover medical expenses as well as compensation for pain and suffering. It is possible a MicroPort/Wright Profemur hip MDL may be established in the near future.  

 

MicroPort/Wright Medical Profemur Modular Neck and the FDA

Following the MicroPort/Wright Medical Profemur hip original FDA approval, it was not long until adverse event reports began filtering in to the agency. Like most of the hip implants and hip implant components which have been recalled over the past few years, the Wright modular neck was not expected to cause trouble, and was touted as revolutionary design which would allow “soft tissue balancing and easy restoration of the hip joint center of rotation.” The implant was intended to provide surgeons with a variety of options for primary and revision hip center, yet patients ended up being injured by the device.

 

Hip implants which are improperly designed can obviously be counterproductive, adding to patients’ health problems rather than solving them. Like many other hip devices, the MicroPort/Wright Medical Profemur Varus/Valgus modular neck was approved under the somewhat controversial 501(k) FDA process which fast-tracks medical device based on their substantial similarity to another device already on the market. The MicroPort/Wright Medical Profemur Varus/Valgus modular neck recall—along with many other hip recalls—has shown fast-tracking medical device approval may not be in the best interests of patients.

 

Microport/Wright Medical Profemur Modular Neck FAQs

If I have a Profemur Hip System with a recalled varus/valgus modular neck, what should I do? Since all lots of the Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254 are affected, and nearly 11,000 of the devices are being recalled, it is important for those who have received the implant to be alert for any signs of failure. Those patients who experience any sudden pain in the hip region, any loss of mobility or any tingling or loss of feeling in their hip or leg should seek immediate medical attention. If the device has failed, the patient will likely undergo MicroPort/Wright Medical Profemur hip revision surgery.

 

Does the FDA recommend revision surgery for those with a Profemur recalled varus/valgus modular neck? At this time, the FDA is not telling all patients with a MicroPort/Wright Profemur hip varus/valgus modular neck recall to undergo hip revision surgery. Unfortunately, there appears to be no diagnostic test or physician exam which can predict that a recalled Profemur neck will fail. The FDA is only saying patients who are not experiencing any current symptoms associated with the recall should take no further action, but should continue to follow up with their health care provider at regular intervals.

 

MicroPort/Wright Medical Profemur Modular Neck Legal Help

If you are one of the many patients who has suffered injury from the recalled Profemur neck component, you could be entitled to MicroPort/Wright Medical Profemur hip monetary compensation. You may be entitled to medical expenses, pain and suffering, lost wages and other applicable compensation. It is important that you speak to an experienced Sullo & Sullo attorney regarding your injuries in order to avoid missing the MicroPort/Wright Medical Profemur hip statute of limitations. For MicroPort/Wright Medical Profemur hip legal help contact a knowledgeable Sullo & Sullo attorney who can answer your questions and assist you in recovering compensation for your damages.





Risk of Metallosis from the Wright-Conserve Total Hip System &the Profemur Total Hip System

Metal-on-metal hip implants were designed in response to the increasing number of younger, more active people who were finding their joints were wearing out long before they were ready to retire to more sedentary lifestyles. The all-metal hip implants were expected to last much longer than the ceramic or plastic implants—as long as 20 years. Soon after the introduction of the all-metal hip implant, however, problems began to arise. Although each manufacturer of the metal-on-metal hip implants had their own unique design—many of which created more problems for recipients—what they had in common was the potential for causing metallosis.

The metal components of the various hip implants rubbed against one another, leading to metal shear and causing microscopic metal ions to enter the bloodstream and the tissues surrounding the implant. Even in the designs which implemented a ceramic ball, it was found later that the metal neck junctures and metal trundles on either end of the neck could trap body fluids, causing corrosion and leading to metallosis just like their all-metal counterparts. The Wright Profemur and Conserve hip implants have both been associated with early failure and femoral neck fracture although neither model has yet been recalled.

The friction between the cobalt and chromium components of the hip systems lead to metal shear, which in turn can cause serious health issues for the recipients of the implants. When the metal ions become lodged in the tissues surrounding the hip implant they can cause severe inflammation and cause pain for the patient. As the metal ions continue to accumulate in the tissues, bone loss, tissue death and eventual loosening and failure of the implant can occur. When the situation becomes this advanced, there is little choice but for the patient to undergo a revision surgery and have the defective hip implant removed and replaced. Metallosis is a result of high levels of metals building up in the body and patients who have metallosiscould be subject to serious and long-term health problems.

  • Hypothyroidism
  • Heart problems
  • Neurological problems, including memory loss
  • Emotional issues such as irritability, depression and anxiety
  • Skin problems
  • Vision and hearing disturbances
  • DNA alterations
  • Renal problems
  • Pseudo tumors

Doctors don’t quite yet understand why bodies react differently to levels of cobalt and chromium; some patients with very elevated levels of cobalt and chromium have few, if any, symptoms. In other cases, persons with relatively low levels of cobalt and chromium end up having serious health issues. Sensitivity to metals is a bit like allergies in that each body will react differently to individual substances. If you are the recipient of a Wright-Conserve or Profemur total hip system, see your doctor to discuss the potential risks. Further, it can be advantageous to consult a knowledgeable products liability attorney to discuss your potential options regarding your metal hip implant.

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