Birmingham Hip Modular Heads 의 안전성 경고

Safety alert

2012-09-25

2012-09-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120925.html

Medical device safety alert: smith and nephew birmingham hip modular heads medical device manufacturer, smith and nephew, has issued a field safety notice concerning birmingham hip modular heads. according to the manufacturer, the average revision rate for the birmingham hip modular head with all stems is currently 1.29 revisions per 100 observed component years in the national joint registry of england and wales and 1.12 revisions per 100 observed component years in the australian orthopaedic association’s national joint replacement registry. these rates exceed the 1% benchmark revision rate established by the uk’s national institute for health and clinical excellence. however, if combined with the uncemented synergy stem, the revision rate is 1.07 revisions per 100 observed years which is acceptable and comparable to other clinically successful hip implants on the market. owing to the above reason, the manufacturer has updated the device’s instructions for use (ifu) (lit. no. 81036947 rev d 03/10 for the application of the birmingham hip modular head). a new stand-alone ifu for the affected product is issued, which includes updates on the contraindications, indications and additional warnings. the sections “information on hydroxyapatite implants” and “information on porous coated implants” that are specific to cups have been removed from the ifu. furthermore, the manufacturer advised users to use the affected product only in accordance with the revised indications for use in the revised ifu. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 25 september 2012.