DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants 의 안전성 경고

Safety alert

2017-09-15

2017-09-15

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170915b.html

Medical device safety alert: depuy delta xtend reverse shoulder system modular centered and eccentric epiphysis implants medical device manufacturer, depuy, has issued a medical device safety alert concerning its delta xtend reverse shoulder system modular centered and eccentric epiphysis implants. the affected devices are identified as the following:- part description: i) modular centered epiphysis size 1 ha; ii) modular eccentric epiphysis size 1 left ha part numbers: i) 130720101; ii) 130720102 lot numbers: i) 5281492 and 5276801; ii) 5289608 and 5280184 the manufacturer’s investigation determined that the affected lots produced in a specific machine were manufactured in a manner in which the post’s diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) may not be able to be assembled. according to the manufacturer, there are two potential instances in which the patient could be affected: if the epiphysis does not assemble to the stem and an alternative device is available, there may be a surgical delay of 15 to 59 minutes. if the epiphysis does not assemble to the stem and there is not an alternative implant available, the patient’s wound may need to be closed and the patient scheduled for a reoperation when a suitable device is available. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 september 2017.