The FDA Issues a Hip Recall for MicroPort Orthopedics

The U.S. Food and Drug Administration (FDA) has issued a Class 1 hip replacement recall for the PROFEMUR Neck Varus/Valgus CoCr 8 Degree (Part number PHAC 1254), which is manufactured by MicroPort Orthopedics. MicroPort Orthopedics has a variety of hip joint replacement systems that allow the surgeon to fit the implant specifically to the patient. The PROFEMUR Neck Varus/Valgus CoCR, part number PHAC1254 is the modular neck being recalled.

On August 7, 2015, distributors and hospitals were informed of a voluntary hip replacement recall by MicroPort Orthopedics Inc. Surgeons, managers, distributors and hospitals were instructed to cease distributing and using the PROFEMUR Neck Varus/Valgrus CoCr 8 Degree for hip replacement surgeries. After the voluntary recall, the FDA issued a Class 1 recall for the product. Class I recalls are the most serious type of recalls and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

There are many reports showing a high rate of fractures to the modular neck following hip replacement surgeries when using the MicroPort Orthopedics product. These fractures will result in the patient feeling sudden pain, instability and difficulty walking. Emergency surgery is required because a fracture increases the chances of hematoma, internal bleeding, neurovascular damage and possible death. The patient requires a revision hip replacement surgery to remove the PROFEMUR Neck Varus/Valgrus CoCr 8 Degree and replace it with a new neck and stem.

If you have had a hip replacement surgery using the MicroPort Orthopedics PROFEMUR Neck Varus/Valgus CoCr 8 Degree product, you should continue to follow the instructions provided by your healthcare professional. Not every patient who has received a hip replacement using the MicroPort Orthopedics hip will experience a fracture. There is currently no evidence that modular neck fractures can be anticipated by patient history, physical exam, visual inspection or by using any imaging modality including X-ray, MRI, or CT scans. Patients should seek immediate medical treatment if they experience any sudden onset of severe pain in their post-operative hip, difficulty or inability walking, significant trauma to their hip or leg (e.g. falling), or a tingling sensation or loss of feeling in their leg.

The Lanier Law Firm is one of the nation’s leading personal injury law firms that focuses in on hip replacement litigation. Our firm has helped countless victims of defective artificial hips and has the experience and expertise to hold corporations like MicroPort Orthopedics Inc. accountable. With offices in Houston, Los Angeles, and New York, The Lanier Law Firm is committed to addressing client concerns with effective and innovative solutions in courtrooms across the country.

If you or a loved one has had revision surgery to remove the MicroPort Orthopedics hip please contact us today at 1-800-723-3216 or contact us online.

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