FDA Issues Class I Recall of DePuy LPS Diaphyseal Sleeve Used in Knee Revision System, Parker Waichman Recounts

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The U.S. Food and Drug Administration (FDA) has issued a class I recall of the DePuy LPS Diaphyseal Sleeve used in the LPS System; this end-stage revision knee device is used in patients who have severe soft tissue damage or bony defects. According to the FDA, the connection between the sleeve and the base may not be able to sustain the physical load in some patients, potentially causing the sleeve to fracture and leading to loss of function or loss of limb, infection, compromised soft tissue or death.

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According to the agency’s recall notice, this can lead to a number of serious side effects, including death.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is informing consumers about a class I recall of the DePuy LPS Diaphyseal Sleeve used in the LPS System. The U.S. Food and Drug Administration (FDA) has recalled the product due to the risk of fracture when the connection between the sleeve and the base is not able to sustain the physiological load in a patient. According to the agency’s recall notice, this can lead to a number of serious side effects, including death.

“This recall may have serious implications for patients implanted with the LPS Diaphyseal Sleeve,” said Daniel C. Burke, Senior Litigation Counsel at Parker Waichman LLP. “A class I recall is the FDA’s most serious recall status; it means that there is a reasonable risk for serious injury or death.” Parker Waichman LLP offers free legal advice to patients who have been implanted with the product, and advises them to see their surgeon if they are concerned about the risk of complications.    

According to an FDA safety notice issued February 22nd, the LPS Diaphyseal Sleeve was recalled because the taper connection between the sleeve and the base may not be sufficient to handle the physiological load during normal everyday activities in some patients. The agency said that this presents a risk of fracture in the sleeve at the taper joint, potentially leading to:

  •     Loss of function
  •     Loss of limb
  •     Infection
  •     Compromised soft tissue
  •     Death

The sleeves were manufactured between 2008 and July 20, 2012. So far, the FDA says it has received a total of 10 reports of the device malfunctioning, including 6 cases of fracturing and 4 reports of loosening. According to the FDA, DePuy issued an Urgent Medical Device Recall on January 4th warning surgeons and hospitals to stop using the device.

The LPS Diaphyseal Sleeve is used in conjunction with the Limb Preservation System (LPS), an end-stage revision knee device used to reconstruct severe soft tissue and bony defects. According to DePuy, the LPS replaces “the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia.” Components such as the sleeve are used when patients have bone loss or defects related to bone tumors resection, trauma, infection and difficult revision arthroplasty. Some of the most common adverse events associated with the device include a change in the position of the components, loosening, bending, cracking, fracture, deformation or wear of components, fatigue fractions, infection, tissue reaction to wear debris, pain, dislocation, decreased range of motion and loss of limb.

Parker Waichman LLP continues to offer free legal consultations to victims of alleged knee implant failures. If you or a loved experienced complications, including loosening or premature implant failure, following total knee replacement with a DePuy LPS Diaphyseal Sleeve component used in the LPS system, please contact their office by visiting the firm's DePuy LPS Diaphyseal Sleeve Lawsuits page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636

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Gary Falkowitz
Parker Waichman LLP
1-800-529-4636
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