According to the FDA on January 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements. If a medical facility has the affected product in stock, it should be returned to DePuy. DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms. The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX. Contact us for a free case appraisal.
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