October 2, 2015 — MicroPort Orthopedics Inc. has recalled about 10,825 hip implant components because they can break.
The part being recalled is the PROFEMUR Neck Varus/Valgus CoCR (Part #PHAC1254), manufactured from June 2009 to July 2015.
The recall began in August after the company received reports of an “unexpected rate of fractures after surgery.”
MicroPort makes a variety of hip replacement systems that allow a surgeon to fit the implant to each patient. The PROFEMUR is a modular-neck — an interchangeable component between the femoral stem and the femoral head.
If the modular neck fractures, the patient may experience sudden pain, instability, and problems walking or performing tasks. According to the recall:
“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.”
The company recommends that patient should seem emergency medical treatment if they experience any of the following symptoms:
- Sudden onset of severe pain in their post-operative hip
- Difficulty or inability walking
- Significant trauma to their hip or leg (e.g. falling)
- Tingling sensation or loss of feeling in their leg
The recall has been declared a Class 1 recall, which is the most serious type and reserved for devices that have a good chance of causing serious injury or death to a patient.
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