VAIOS Total Shoulder Replacement System 의 안전성 경고

Safety alert

2015-10-23

2015-10-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151023.html

Medical device safety alert: orthotech vaios total shoulder replacement system the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning vaios total shoulder replacement system, manufactured by orthotech. the manufacturer, in consultation with the tga, has issued a hazard alert for the vaios total shoulder replacement system due to higher than expected revision rates. the manufacturer ceased supply of the affected device on 14 august 2015 after cancellation from the australian register of therapeutic goods. information published by the australian orthopaedic association's national joint replacement registry (aoanjrr) indicated that, to december 2013, the affected device had a revision rate at two years of 17.6%. the comparable revision rate at two years for all other total conventional shoulder implants was 5.5%. this data indicated that, at december 2013, the affected device was four times more likely to need revision than other conventional shoulder implants. the tga analysed additional data from the aoanjrr collected to december 2014 and found that the revision rate of the implant was not improving. the manufacturer is advising clinicians to consider contacting patients who have been implanted with these devices to inform them of this issue. implanting surgeons are advised to maintain their routine follow-up protocol for patients who have undergone shoulder arthroplasty. the need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patient’s clinical circumstances. preventative removal of implanted devices is not recommended at this time, as the risks of additional surgery outweigh the benefits if no problems are being experienced by the patient. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00976-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 october 2015.