FDA Recalls MicroPort Orthopedics’ Hip Replacement Component
The U.S. Food and Drug Administration announced the recall of the MicroPort Orthopedics Inc.’s Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. The prosthetic is used in total hip replacement procedures.
During total hip replacement surgery, doctors remove the damaged portion of the patient’s hip joint and replace them with prosthetic parts including a femoral head, femoral stem and modular neck. The product being recalled is the modular neck of a MicroPort total hip replacement system.
According to the FDA, MicroPort Orthopedics has received reports of a higher than expected rate of fractures after hip replacement surgery involving the Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254.
If the modular neck fractures, a hip replacement patient may suffer sudden intense pain, instability, difficulty walking and difficulty performing common tasks.
Some acute fractures may require emergency surgery to remove the defective part and replace the prosthetic neck and stem, according to the FDA. Patients who suffer a serious fracture may experience neurovascular damage, internal bleeding, hematoma, and potentially fatal complications.
The FDA designated the recall as a Class I recall which is the most serious type of recall due to the probability that the medical device will cause serious harm or death to patients.
MicroPort Orthopedics notified hospitals and product distributors of the product recall on Aug. 7, 2015 and informed surgeons to stop using the product and return it to the MicroPort Distribution Center, 11481 Gulf Stream, Arlington, TN 38002. The recall involves 10,825 medical devices that were manufactured from June 15, 2009 to July 22, 2015.
Patients should visit their doctor and get prompt medical treatment if they have any sudden serious pain in the replaced hip, a tingling sensation or loss of sensation in their leg or difficulty walking.
What to Do If You Have Experienced Complications of MicroPort Orthopedics’ Hip Replacement System
The defective medical device attorneys at Hardison and Cochran are investigating cases of harm to patients involving the recalled MicroPort Orthopedics Inc. total hip replacement system. If you or a loved one has undergone total hip replacement surgery involving this MicroPort Orthopedics’ product and experienced complications including the need for follow-up surgery, you may be entitled to compensation.
Please contact us so that we can review the specifics of your case free of charge and explain your legal options. We would like to help you obtain the compensation you deserve to cover your medical bills and other losses if you have been harmed by a defective medical device.