|DePuy is recalling part of its Limb Preservation System.--Courtesy of DePuy|
Johnson & Johnson's ($JNJ) DePuy unit is recalling the diaphyseal sleeve shipped with its Limb Preservation System, warning that the sleeve may fracture as patients walk, possibly resulting in infection or loss of limb. The FDA has assigned its most-serious Class I label to the recall, saying the malfunction could lead to serious injury or death.
The Limb Preservation System is used to reconstruct severe soft tissue and bone defects in patients' knees, and the sleeve is designed to help fit the implant in place.
In January, DePuy informed its customers that the taper connection between the sleeve and and the implant's base may not be strong enough to support some patients' movements, leading to breakage that could result in loss of function, loss of limb, infection or death. The FDA applied the Class I designation this week and is asking customers to report any adverse events through its online MedWatch program.
The agency has so far received 10 such reports: 6 all-out sleeve fractures and four cases of loosening that may or may not stem from the same problem.
DePuy is not recommending revision surgery in the absence of symptoms, however, instead telling physicians to discuss the risks with their patients and keep a close eye on potential problems.
- read the FDA's note