Depuy Orthopaedics Recalls Lower Leg Implant
The FDA warns surgeons to immediately stop using the device.
Published: August 5, 2013
Depuy Orthopaedics has recalled the LPS Intercalary Dovetail Joint implant because the female end of the device could fracture after implantation when exposed to the normal physiologic loads of walking.
Depuy sent an urgent letter to distributors, hospitals and surgeons on July 11, asking them to immediately stop distributing or using the recalled lots. The FDA followed with a Class I recall on July 31, which lists the recalled lot numbers.
A Depuy spokeswoman says the implant is part of a system used to reconstruct severe soft tissue and bone defects in the thighbone. She explains that a portion of the implant has the potential to break, which could cause instability of the thighbone or pain, leading to a patient's inability to put weight on the operated leg. The company has received 7 complaints of device fracture after distributing approximately 96 implants in 8 countries from 2006 to 2013.
According to the spokeswoman, the risk of breakage increases in heavier patients, especially those weighing more than 200 lbs., and during activities such as walking and climbing stairs. The company isn't recommending replacement of the implant in the absence of symptoms, but surgeons are encouraged to communicate with patients who received the implant to discuss the risks of fracture and potential complications, which, says the FDA, include infection, loss of function, loss of limb, neurovascular injury or the need for revision surgery.
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