Events

Recall of Durolane 3ml (synovial fluid supplementation substance)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00779-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00779-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has advised that there has been a higher than anticipated number of reports of post-injection knee pain and swelling. in some cases an increase in the intensity of the symptoms have been reported. pain, swelling and stiffness may limit mobility or use of the limb. recovery time might be increased and moderate to severe patient discomfort may result. some patients may have swelling due to varying degrees of effusion and which may require aspiration. most patients involved with the reported complaints recovered within the listed timeframe in the ifu and known from the clinical studies of the product. few patients had a protracted recovery time beyond 3 weeks after injection.
  • Action
    Please report any issues or adverse reactions to the TGA (refer to "Report a problem with a medical device" http://www.tga.gov.au/safety/problem.htm#device) and to Smith & Nephew Surgical. Customers with affected units are requested to advise Smith & Nephew so that replacement stock can be arranged.

Device

Durolane 3ml (synovial fluid supplementation substance)
  • Model / Serial
    Durolane 3ml (synovial fluid supplementation substance)Product Number: 1081110Batch Number: 12068-1ARTG Number: 200304
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd