DePuy Othopaedices, a subsidiary of Johnson & Johnson, is recalling an implant used to replace part or all of the femur bone. The device could fracture when exposed to normal weight loads while walking, which can cause pain, infection, loss of limb, neurovascular injury or the need for revision surgery. Patients heavier than 200 pounds and those who are highly active are at greater risk for fracture.
DePuy has notified doctors and hospitals of the defect with the LPS Lower Extremity Dovetail Intercalary component. The medical device company is also providing surgeons with a patient letter template for notifying their patients and discussing the risks of the implant fracture and the method for detecting implant failure. DePuy is not recommending revision or additional follow-up for patients who are not experiencing symptoms.
The recall involves 31 lots of the device, which were distributed between February 2007 and May 2013. The recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The action brings to mind another major DePuy recall that affects an estimated 93,000 people worldwide. In 2010, DePuy recalled its ASR metal-on-metal hip replacement system after reports showed the device was failing at a faster than expected rate in just five years or less. The all-metal implant was also in some cases leeching metal ions into the bloodstream of patients causing a type of blood poisoning known as metallosis. The first of thousands of DePuy-Johnson & Johnson metal-on-metal hip implant lawsuits was heard just months ago and resulted in an $8.3 million award for the plaintiff.