The taper connection between the sleeve and the base may not be able to accommodate the physiologic loads that occur during normal activity. If loads fracture the sleeve at the taper joint, it could lead to loss of function, loss of limb, infection, compromised soft tissue or death, according to the report.
A Class 1 recall is the FDA’s most serious warning. Hospitals and surgeons should immediately stop distributing or using the recalled lots. Currently DePuy is not recommending revision or follow-up for patients without symptoms.
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