MicroPort Orthopedics Recalls PROFEMUR Modular Neck
Oct. 6, 2016
MicroPort Orthopedics, a Tennessee corporation, which manufactures a variety of hip joint replacement systems, has received reports of an unexpectedly high rate of fractures after surgery related to the PROFEMUR 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.
When a patient undergoes surgery to repair or replace a defective hip joint, the damaged portions of the hip are removed and replaced with prosthetic parts, which may include a femoral head, femoral stem and modular neck. In the present recall, the modular neck known as the PROFEMUR Neck Varus/Valgus CoCR, part number PHAC1254 is the specific part being voluntarily recalled by MicroPort due to high failure rates and resulting safety issues with the implant. On August 7, 2015, MicroPort Orthopedics Inc. informed distributors and hospital staff of a voluntary device product recall. Distributors and hospital staff, including risk managers and surgeons, were instructed to immediately stop using and distributing the affected product, and return the recalled product to MicroPort Orthopedics Inc.
All lots of the particular product are affected and the products were manufactured between June 15, 2009 and July 22, 2015. These products were distributed between June 15, 2009 and July 31, 2015 and there are 10,825 recalled devices in the United States. Patients who have been implanted with the recalled device should continue to follow up with their health care providers at regular intervals as prescribed by their surgeons. There is currently no method to anticipate or predict modular neck fractures by patient history, physical exam, visual inspection or by using any imaging modality including MRI, CT scan or X-ray. Patients who are not experiencing any symptoms need not take any action at the present time. However, patients who experience any sudden onset of severe pain in their hip, difficult walking, significant trauma to the hip or a tingling or loss of sensation to the leg, should seek immediate medical treatment as this may constitute a medical emergency.
Class I recalls are the most serious type of recalls and involve situations in which there is a likelihood that the use of the products will cause serious health consequences or even death. If you are a loved one, has been injured by a MicroPort Orthopedics PROFEMUR Modular Neck, contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation or visit us online at www.EnnisLaw.com and fill out an online form.