DePuy Knee Revision Device Issued Class I Recall, FDA’s Most Serious Recall Status

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DePuy Knee Revision Device Issued Class I Recall, FDA’s Most Serious Recall StatusOverview: The U.S. Food and Drug Administration (FDA) has issued a Class I recall for DePuy Orthopaedics’ LPS Diaphyseal Sleeve used in conjunction with the LPS system, which is an end-stage knee revision device. According to the FDA’s notification, the connection between the sleeve and the base may not be able to sustain the physical load in some patients. This may lead to loss of function, loss of limb, infection, compromised soft tissue or death.

  • DePuy’s LPS Diaphyseal Sleeve used in the LPS system has been issued a Class I recall, meaning that use of this device may lead to serious injury or death
  • The recall was issued because the connection between the sleeve and the base may be unable to sustain the physiological load in some patients
  • The FDA has received 6 reports of fractures and 4 reports of loosening related to the device

Product: LPS Diaphyseal Sleeve

Manufacturer: DePuy Orthopaedics

Side Effects & Complications

  • Fracture of the sleeve at the taper joint
  • Loss of function
  • Loss of limb
  • Infection
  • Damaged soft tissue
  • Death

LPS Diaphyseal Sleeve Issued Class I Recall

On Friday, the FDA issued a safety notice stating that the agency has informed healthcare professionals about a Class I recall of the LPS Diaphyseal Sleeve , which is used with the LPS system; the device an end-stage knee revision product that allows surgeons to reconstruct severe soft tissue and bony defects.  The FDA stated that the taper connection between the sleeve and the base may not be able to accommodate the load that occurs during normal, everyday activity in some patients. “This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death. “ the agency warned.

So far, the FDA has received 6 reports of fractures and 4 reports of loosening associated with the sleeve. The devices were manufactured between 2008 and July 20, 2012. In early January, DePuy had issued an Urgent Medical Device Recall telling hospitals and surgeons to immediately stop using the recalled products.

A Class I recall is the FDA’s most serious recall status. It means that exposure to the device presents a reasonable risk of serious injury or death.

DePuy Orthopaedics is a subsidiary of Johnson & Johnson. It is currently in the midst of litigation over the DePuy ASR, a metal-on-metal hip implant that was recalled due to a high rate of failure. Johnson & Johnson also recently recalled another all-metal hip replacement; 7,500 Adept hip implants were recalled in 21 countries outside of the United States due to a high revision rate.