DePuy, a subsidiary of Johnson & Johnson, has issued a recall for the diaphyseal sleeve that comes with the company’s Limb Preservation System. According to information from DePuy, the sleeve may fracture as a patient walks. Under some conditions, this can lead to a serious infection and may require a patient to undergo an amputation.

As of now, the United States Food and Drug Administration has assigned the Limb Preservation System a Class I status, stating that the device could lead to serious patient injury or even death.

According to information from DePuy, the company’s Limb Preservation System is designed to reconstruct soft tissue that has experienced severe injury. In addition, the device can be used to reconstruct bone defects in the knees. The included sleeve helps hold the implant in place.

In January of this year, the company informed impacted customers that the connection between the implant’s base and sleeve may not be strong enough to withstand all of a patient’s movement. If this tapered connection breaks, patient’s could experience a loss of limb function, infection or a loss of limb.

The FDA has requested that customers report adverse events through the agency’s MedWatch reporting program.

References

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm340708.htm

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