advertiser banner advertiser banner
Digital Issues

Home >  News >  August, 2013

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.

Daniel Cook


Also in the News...

Outbreak at Seattle Hospital Infects at Least 35, Suspected in 11 Deaths
Unfiltered OR Lights Burn Patients at Oregon Hospital
Wyoming ASCs' Recovery Care Proposal Iced
UPDATE: Boston Hospital Surgeon Dies After Shooting
Court Overturns $12 Million Defamation Judgment Against Plastic Surgery Patient
Yorkville Endoscopy Loses AAAASF Accreditation
Florida Facilities Guarantee Successful Spine Outcomes

 
Have an account? Please log in:
Email Address:
  Remember my login on this computer

DID YOU SEE THIS?
Medications and Med Mgmt

Transforming Medication Delivery

advertiser banner

Other Articles That May Interest You

Recalled Tracheal Tube Could be Deadly

Teleflex says product can kink during use.

Hospira Recalling Propofol, Lidocaine

Teleflex Recalls Anesthesia Circuits

Devices may crack, hindering airway-based care.