ATTENTION: FDA Recalls Hip Implant Component
If you or a loved one has received a hip replacement surgery between June 15, 2009 and July 31, 2015, please consult with your medical professional in regards to the type of prosthetics used during the surgery.
On October 2, 2015 the Food and Drug Administration (FDA) announced a Class I recall of nearly 11,000 PROFEMUR Modular Neck component pieces used in hip replacement surgeries (partnumber PHAC 1254).
Class I recalls by the FDA 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.
This recall comes in the aftermath of an unexpectedly high number of hip implant fractures being reported that involved this device. From the FDA Safety Recall Notification:
MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck. If the modular neck fractures, the patient may experience 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 and could lead to neurovascular damage, hematoma, hemorrhage, and even death.
It is extremely unfortunate whenever a product of this type has a life-threatening defect. In most cases, the products were tested thoroughly, and these defects are anomalies. However, if there are continuing reports of product defects, investigations will be held by the FDA and if found liable, manufacturers will be responsible for damages stemming from the defects.
The FDA urges patients of this product to seek immediate medical treatment if they experience any of the following:
- Sudden onset of severe pain in their post-operative hip
- Difficulty or inability walking
- Significant trauma to their hip or leg (e.g. falling)
- A tingling sensation or loss of feeling in their leg
If you are a patient who has had hip replacement surgery involving this product and are interested in learning more about your legal rights, you are welcome to call our office (888) 783-8378 and speak with an experienced defective hip attorney today.