An Overview of the MicroPort PROFEMUR hip recall
MicroPort Orthopedics Profemur Modular Neck Hip Implant Failure Recall (The Legal Examiner)
Another metal hip implant fiasco and recall has hit the airways and garnered the strongest warning/recall from the FDA.
The FDA recently announced the Profemur hip recall for the Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, noting that it is a Class I medical device recall.
11,000 Affected Profemur Modular Neck Components
There are high rates of hip implant fractures has led to the recall of nearly 11,000 Profemur Varus/Valgus modular neck components for artificial hip replacement systems.
MicroPort Orthopedics Inc. Under Fire For Defective Parts
The manufacturer, MicroPort Orthopedics Inc., has been blamed for many reports of the Profemur hip implant components fracturing suddenly after surgery. This sudden and unexpected fracture can cause extreme pain, difficulties walking and general instability.
MicroPort Orthopedics Inc., was established in January 2014, and is the fourth largest multinational producer of orthopedic products, based in Arlington, Tennessee.
What is A Class 1 FDA Recall?
Class I recall is the most serious classification that can be given to a medical device recall. This recall means that the according to the FDA, these metal hip implants have a reasonable probability of causing a serious injury or death.
The FDA warned, “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.”
Recalled MicroPort Orthopedics Components
During total hip replacement surgery, the damaged portions of the hip joint are removed and replaced with artificial parts including a femoral head, femoral stem and modular neck.
The PROFEMUR Neck Varus/Valgus CoCR, part number PHAC1254 is the modular neck being recalled.
MicroPort informed distributors and hospitals about the recall on August 7. The recall affects all lots of the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. The parts were manufactured from June 15, 2009 to July 22, 2015, and distributed from June 15, 2009, through July 31, 2015.
Product: PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254
- All lots are affected
- Manufactured from: June 15, 2009 to July 22, 2015
- Distributed from: June 15, 2009 to July 31, 2015
- Devices Recalled in the U.S.: 10,825
MicroPort New Profemur Modular Neck Manufacturer
In August 2013, MicroPort started manufacturing the Profemur hip implant when it took over Wright Medical Group’s OrthoRecon business.
Similar severe personal injury and defective product liability claims were noted with Profemur hip implant femoral neck devices. Again, patients developed severe and serious injuries when the modular femoral neck fractured or broke.
Wright Profemur Lawsuits
The Conserve and Profemur metal hip implants have been associated with severe and serious hip replacement complications in patients.
The flexible neck of the Profemur component is subject to fracture, which can result in inflammation, pain, and difficulty walking; breaks in the femoral stem often require a revision surgery.
The Conserve hip replacement has a metal-on-metal ball and cup design. Unfortunately, when the two metal components grind against one another, there are metal particle debris that enter the blood or deposits in local hip tissue. This side effect causes metal poisoning, also known as metallosis.
Wright settled two PROFEMUR lawsuits in 2013, just before they were scheduled to go to trial. Many suits have also been filed against Wright Medical for injuries associated with the CONSERVE hip replacement systems, including metallosis and sudden failure of the hip implant requiring hip implant revision.
These lawsuits were consolidated and centralized under one judge in the U.S. District Court for Northern Georgia, as a multidistrict litigation or MDL.
Several Profemur hip lawsuits were filed over personal injury and defective designs associated with the implant, most of which were settled by Wright Medical Group in the past 2 years.
MicroPort’s Hip Implant Recommendation
MicroPort recommends that patients who have already had one of the recalled Profemur hip components implanted, should seek medical evaluation immediately if they develop sudden pain after a hip implant, or if they develop difficulty walking or a loss of feeling in their leg.
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