Hip Implant Recall
Written by Faith Anderson on October 6, 2015
High Failure Rate Leads to Class I Recall of Profemur Modular Neck Implant
The U.S. Food and Drug Administration (FDA) has announced the recall of nearly 11,000 Profemur Varus/Valgus Modular Neck hip implant components, due to an unexpectedly high rate of hip implant fractures and failures. The FDA announced the hip implant recall for the Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck on October 2, and categorized it as a Class I medical device recall, which is the most serious type of recall the FDA can issue. If you received a Profemur artificial hip in the past, and you have since suffered complications like hip implant failure, fracture of the artificial hip, or problems like pain and difficulty walking, contact an experienced product liability lawyer today to discuss filing a defective hip implant claim against the device manufacturing company.
Profemur Hip Implant May Fail Prematurely
During total hip replacement surgery with the Profemur hip implant, the damaged portions of the hip joint are removed and replaced with a prosthetic hip device featuring a femoral head, femoral stem and modular neck. In most cases, artificial hip implants are designed to last for 10 to 15 years, but when the hip device fails in a higher-than-expected number of cases, a recall sometimes becomes necessary. According to this latest hip implant recall, the manufacturer of the Profemur hip implant, MicroPort Orthopedics Inc., has received an unexpectedly high number of adverse event reports involving the hip components fracturing after surgery, which can lead to complications like sudden pain, instability, and difficulty walking and performing common tasks.
Hip Implant Affected by Class I Recall
MicroPort first warned distributors and hospital staff of the Profemur recall on August 7, several months before the FDA made its recall announcement to the public, and its designation as a Class I recall means that federal regulators have reason to believe the Profemur Modular Neck hip implant poses a risk of serious injury or death for implant recipients. According to the FDA, the hip implant recall affects all lots of the Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part Number PHAC 1254, manufactured between June 15, 2009 and July 22, 2015, and distributed from June 15, 2009 through July 31, 2015.
Problems With Artificial Hip Implants
Artificial hip implants, namely metal-on-metal devices, have come under fire in recent years for a host of problems that have been linked to the medical devices, including device fracture, loosening of the implant, dislocation of the device, and infection injuries, with some of the problems requiring revision surgery to remove or replace the defective device. Unfortunately, revision surgery itself is sometimes associated with devastating complications, and as the FDA warned in its Profemur recall announcement, “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 and could lead to neurovascular damage, hematoma, hemorrhage, and even death.”
MicroPort began manufacturing the Profemur hip implant after acquiring Wright Medical Group’s OrthoRecon business in August 2013, but similar problems were reported with Profemur femoral necks prior to the company changing hands, including instances where the modular femoral neck fractured or broke, causing patients to suffer a catastrophic implant failure. That means that MicroPort likely knew or should have known about the risk of its Profemur hip implants failing prematurely and causing serious injuries for patients, yet withheld information about this risk from consumers and the medical community.
Lawsuits Filed Over Hip Implant Failure
A number of Profemur hip implant lawsuits were brought against, and settled by, Wright Medical Group in 2013 and 2014, over alleged defects in the design of the artificial hip, which caused serious complications in implant recipients. In November 2013, Wright Medical Group reportedly settled a defective hip implant lawsuit alleging premature failure of a Profemur device for an undisclosed amount, just days before it was scheduled to go to trial in the U.S. District Court for the Middle District of Georgia. That same month, DePuy Orthopaedics agreed to settle thousands of complaints brought over injuries from its ASR metal-on-metal hip implant, which was recalled back in August 2010, for $2.5 billion.
Contact an Experienced Hip Implant Lawyer Today
For patients who have had a recalled Profemur modular hip implanted in recent years, MicroPort recommends seeking immediate medical treatment should complications like pain, difficulty walking, or a tingling feeling in the leg occur. For its part, MicroPort has asked hospitals and distributors to review the recall announcement and discontinue using the Profemur devices for hip implant procedures. If you believe you have been adversely affected by side effects of an artificial hip implant, like the recalled Profemur modular neck device, consult a knowledgeable attorney to discuss your legal options. With a qualified lawyer on your side, you can ensure that your legal rights are protected, and pursue the financial compensation you deserve for your injuries and medical expenses.