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The FDA announced a Class I Recall – the most serious type of recall – on yet another hip implant device. According to the FDA alert, MicroPort Orthopedics received “reports of an unexpected rate of fractures after surgery related to” its PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254.
During a total hip replacement surgery, the damaged portions of the hip joint are removed and replaced with prosthetic parts including a femoral head, femoral stem, and modular neck.
MicroPort’s PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254 is the modular neck being recalled.
A total of 10,825 units from all lots of the device are affected by the recall, which were manufactured from June 15, 2009 to July 22, 2015 and distributed between June 15, 2009 and July 31, 2015.
MicroPort first informed distributors and hospitals about the recall of the product on August 7, 2015. The FDA release noted that use and distribution of this product should cease and modular neck PHAC1254 should be shipped to MicroPort’s distribution center in Arlington, Tennessee.
Fractures can cause inflammation, sudden pain, instability, and difficulty walking and performing common tasks.
“An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence.” This can lead to:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Should you experience any sudden onset of severe pain in your post-operative hip, find it difficult or you are unable to walk, experience significant trauma to your hip or leg or tingling sessions or loss of feeling in the leg, contact your doctor immediately.
Profemur products were formerly manufactured by a division of Wright Medical. In August 2013, MicroPort started manufacturing the PROFEMUR hip implant when it took over Wright Medical Group’s OrthoRecon business.
Similar problems were reported with the Profemur neck before MicroPort acquired Wright Medical. A number of lawsuits were filed over personal injury and defective design defects associated with the device; however, most were settled by Wright Medical Group in the past couple of years.
Any hip replacement can become a medical problem to a patient who has a severe reaction; however, the neck of a modern hip replacement stem should not fracture. Contact the personal injury lawyers at Nash & Franciskato for a free, no-obligation evaluation of your case.