Radial Head Prosthesis System 의 안전성 경고

Safety alert

2017-01-10

2017-01-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170110c.html

Medical device safety alert: depuy synthes radial head prosthesis system medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning the removal of its radial head prosthesis system. the entire depuy synthes radial head prosthesis system is affected by this removal, however it is the radial stem that has the possibility of loosening post-operatively at the stem bone interface. based on the currently available data, the manufacturer believes the cause to be multifactorial (including possible product characteristics, operative and patient factors), but they have not been able to fully characterize these factors. consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and has decided to remove the depuy synthes radial head prosthesis stem from the global market. health care practitioners that have treated patients using the affected products should continue to follow those patients in the usual manner. according to the manufacturer, if the radial stern becomes loose post-operatively, the following may occur: device loosening, osteolysis, poor joint mechanics, pain, bone fracture - post-operatively, and soft tissue damage (soft tissue irritation). the manufacturer is requesting users to immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. the affected products should be returned to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 january 2017.