Birmingham Hip Resurfacing (BHR) System 의 리콜

Recall

RC-2015-RN-00080-1

Class II

2015-02-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00080-1

Smith & nephew has updated the instructions for use of the birmingham hip resurfacing (bhr) system to include an expansion of the warnings for certain population sub-groups, in line with available data sources including registry data. the ifu has been updated to note that: if a patient from the following population sub-groups is implanted with a bhr system, the patient is at greater risk of requiring a revision surgery earlier than expected: (a) females, (b) males aged 65 or greater, (c) patients requiring an implant head size =48m, (d) patients who have a diagnosis of avascular necrosis; and (e) patients who have congenital dysplasia. patients who experience symptoms including pseudotumors, tissue masses, fluid collections, enlarged bursae, pain and swelling, local buildup of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function.

Smith & Nephew is contacting all the implanting surgeons of Birmingham Hip Resurfacing (BHR) system to inform them of the changes to the IFU. Smith & Nephew is recommending the surgeons to use the BIRMINGHAM HIP Resurfacing System only after considering the warning statement and indications for use in the updated IFU attached. Smith & Nephew is further recommending to continue to apply standard practices for patient follow-up care. Smith & Nephew is forwarding the IFU's to two hospitals that have stock on hand. This action has been closed-out on 31/08/2016.