The Food and Drug Administration (FDA) issued a Class I Recall for LPS Diaphyseal Sleeves, commonly used in knee replacement surgeries, on February 15, 2013.
Online, March 14, 2013 (Newswire.com) - The Food and Drug Administration (FDA) issued a Class I Recall for LPS Diaphyseal Sleeves, commonly used in knee replacement surgeries, on February 15, 2013. A Class I Recall is the most severe recall issued by the FDA, indicating the potential for serious injury or death.
On January 4, 2013, DePuy Orthopedics, Inc., manufacturer of the LPS Diaphyseal Sleeve, alerted hospitals and surgeons to cease the distribution and use of these implants, due to the possibility that the devices may be unable to support a patient's weight while the patient is walking or engaging in other physical activity. According to the FDA, this is because the taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
DePuy's Limb Preservation System (LPS) is used to reconstruct soft tissue and bones in knee replacement surgeries. According to Depuy, the LPS "is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia." This complex procedure includes the use of the LPS Diaphyseal Sleeve to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements. The LPS Diaphyseal Sleeve implants listed in the recall were manufactured from 2008 until July 20, 2012.
Complications with the LPS Diaphyseal Sleeve may result in a fracture that could lead to a loss of function of the limb, loss of the limb, infection, compromised soft tissue, or even death. So far, the FDA has received a total of 10 reports of incidents in which the device has malfunctioned. These reports include 6 fractures and 4 reports of loosening that may be attributed to this device. Adverse events associated with the LPS Diaphyseal Sleeve that may indicate serious complications include:
• change in position of the components,
• loosening, bending, cracking, fracture, deformation or wear of one or more of the components,
• fractures of the femur or tibia,
• infection,
• pain, dislocation, subluxation, flexion contracture,
• decreased range of motion,
• lengthening or shortening of leg caused by improper positioning,
• possible loss of limb if complications occur
If you or a loved one have experienced complications, such as the ones listed above, please contact Keefe Bartels, LLC, immediately by calling 1-877-ATTY-24-7. Attorneys at Keefe Bartels, LLC, are available for free legal consultations to victims of alleged knee implant failures.
Keefe Bartels, LLC, handles complex medical device implant litigation throughout the nation. The firm's offices are headquartered in New Jersey. For more information, please visit the firm's website at www.defectivejoints.com.
Share: