Wright Hip Replacement Implant Recall Lawsuit

Wright Hip Replacement Implant Recall Lawsuit

Wright Hip Replacement Implant Recall Lawsuit

 

Wright Hip Implant Lawsuit

chp_artificial_hipNumerous complaints have been registered against Wright Medical Technology for marketing defective Profemur® Z hip implant device, which is reported to have a high failure rate of 11.2 percent. It has been reported that the hip implants fail merely three years after implantation – of every nine patients, one experiences problems with the defective Profemur device.

Patients complain that the main defect with Profemur® Z hip implant system lies with its flexible modular design, which means the neck can easily bend, degrade, break, fret, and ultimately fracture and fail. This creates problems for the patients, who experience stiffness in the groin and find difficulty in performing routine activities; difficulty walking or standing; and experience excruciating pain in the groin, thigh, hip, lower back. Most of the patients are required to undergo a revision surgery, which is even more painful and debilitating compared to the first hip replacement procedure. Surgeons, too, find it difficult to perform secondary procedure, which requires removal of the earlier implanted hip device and replacement with a new one.  A number of patients complain that the Femoral Stem or Neck broke while they were performing normal activities, causing them debilitating injuries.

lawsuit Against Wright Medical Technology

Wright Medical Technology faces numerous product liability lawsuit for manufacturing and marketing defective products. Plaintiffs allege that the defendant company marketed the defective product claiming that these would last about 15 years. Contrary to this, the product lasts

merely three years, which means the patients must get it removed and replaced.  Many lawsuit allege that on launching the defective product, the company claimed that it was an evolutionary design that allows balancing of the soft tissue and “restoration of the hip joint center of rotation.”  In fact, the Profemur Z hip replacement was considered a better implant than all other types of implants.  Since then, the company has been marketing its original hip replacement system, consisting of Wright Modular Femoral Neck, Conserve Plus Cup, and Profemur E Cementless Stem, as the best replacement for a defective hip damaged because of degenerative joint diseases, including dysplasia, traumatic arthritis, osteoarthritis, and rheumatoid arthritis. However, the results have been negative.

 

FDA Approval

Like other manufacturers of hip replacement devices, Wright Medical Technology also exploited FDA’s 510(k) premarket approval process to market its defective product, which it claimed was an innovation in the field of hip replacement technology. It was able to convince the FDA that Profemur Z hip replacement is “substantially equivalent” to the hip replacement systems on the market and secured its approval without undergoing mandatory clinical trials, even though the modular neck portions of its hip devices were an advancement on the fixed necks of previous products.

The manufacturer and the FDA are both at fault for the problems facing victims of these defective hip implant systems. Many product liability lawsuit in the country claim that the product is defective as designed because the femoral stem breaks merely three years after its implantation. Plaintiffs claim compensation for all the physical and emotional pain and suffering they had to undergo following the surgery and the cost of medical bills after their hip replacement surgery failed due to implantation of a defective product.

A surgeon has even complained that while performing a revision surgery, he found that the acetabular cup was not attached to the patient’s pelvis, which is a must for the proper functioning of the entire hip replacement system. Alleging negligence on the part of the manufacturer, plaintiffs claim that the innovative design is itself the product’s weakness, as the flexible hip stem seems to be extremely weak, which makes it to degrade, break, fret, and fracture easily.

The defects in the Wright Profemur hip device were first discovered by the Australian National Joint Registry, which reported more-than-expected failure rate in the product. However, the FDA has not yet issued a Profemur Z hip replacement warning, nor has it asked Wright to recall the defective product.

Earlier, in 2004, Wright Medical Technology had to recall the metal acetabular hip devices over manufacturing deficiencies. It was reported that Wright did not manufacture the product properly, which resulted in a defective product. This meant that the product failed sooner than expected and the patients had to undergo secondary surgeries to get rid of the pain caused by the failure of their hip implant system.

Hip Replacement Implant Recall Lawsuits

The federal government has seen a surge in the number of complaints and reports about failed hip products.  A New York Times analysis indicates that more than 5,000 complaints of product failure have been registered with the FDA since January. An increased number of complaints surround the metal-on-metal hip replacement systems. This clearly shows that serious problems about artificial hips persist in the country, thus posing a number of health risks to the patients.

DePuy Orthopedics has received a number of complaints of product failure and metal toxicity, which causes rashes, pain, and inflammation soon after implantation of the metal-on-metal hip devices, following which removal and replacement of the defective hip product becomes crucial. Some patients have even complained of having suffered crippling injuries due to the tiny cobalt and chromium particles released by the defective metal devices. Despite numerous complaints about metal-on-metal hips, Wright Medical Technology is yet to issue a recall for its metal-on-metal hip implant systems.

In May, the F.D.A. ordered manufacturers of hip replacement systems to study the frequency of failure of their devices and the threat posed to patients.

 

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