The FDA has announced a recall of the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254 (PRFEMUR).
- 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.
Our law firm is investigating this recall. Attorney David Szerlag is providing free consultations to people who have been harmed by this product. You can contact David by using our free consultation form.
The company that issued the recall is MicroPort Orthopedics, Inc.,
5677 Airline Road, Arlington, TN 38002./
How is the PROFEMUR Used?
During total hip replacement surgery, the damaged portions of the hip joint are removed and replaced with prosthetic 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.
What Was the Reason for the Recall?
MicroPort Orthopedics Inc. issued the recall after it 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 a common task. 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.
Recall Information
On August 7, 2015, MicroPort Orthopedics Inc. informed distributors and hospital staff of a recall of the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254, a modular neck device used for hip implants.
The company provided the following instructions for patients:
- Patients should continue to follow up with their health care provider at regular intervals as prescribed by their surgeon.
- There is currently no evidence that modular neck fractures can be anticipated by patient history, physical exam, visual inspection or by using any imaging modality including X-ray, MRI, or CT scans.
- Patients not experiencing symptoms should not take any further action.
- Patients should seek immediate medical treatment if they experience any sudden onset of severe pain in their post-operative hip, difficulty or inability walking, significant trauma to their hip or leg (e.g. falling), or a tingling sensation or loss of feeling in their leg.
Attorney David Szerlag is recommending that patients contact them as soon as possible after experiencing pain from hip replacement surgery. They have handled cases like these involving other manufacturers of other hip implant devices.
Our law firm is calling on additional testing for hip implant devices, given the number of recalled products in the last few years. Patients put their trust in the companies providing the implants, but that trust has been misplaced.
A lawsuit seeks both compensation and justice.