Limb Preservation System Diaphyseal Sleeve 의 안전성 경고

Safety alert

2013-02-25

2013-02-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130225.html

Medical device safety alert: depuy limb preservation system diaphyseal sleeve the united states food and drug administration (fda) has issued a medical device safety alert concerning limb preservation system (lps) diaphyseal sleeve manufactured by depuy orthopaedic inc. the affected devices were manufactured and distributed from 2008 to 20 july 2012. all lot numbers with product codes 1987-20-018, 1987-20-020, 1987-20-024 and 1987-20-028 are affected. according to the manufacturer, the lps diaphyseal sleeve to diaphyseal sleeve base 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. this may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death. 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. depuy advised the affected customers to immediately stop distributing or using the recalled lots. 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 local supplier, johnson & johnson (hong kong) ltd., confirmed that the affected product has not been marketed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm340708.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 february 2013.