Events

Recall of GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate

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-2015-RN-00154-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00154-1
  • 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
    Batch number 14ct39993 of the genesis ii knee system non-porous tibial base plate (model # 71420182) were manufactured with a surface finish that does not meet smith & nephew’s product specification. this could result in poor cement adherence and the loosening of base plate. the device may fail, and revision surgery may be required.
  • Action
    Smith & Nephew is recommending that surgeons follow standard post-operative follow-up protocols and actions for their patients and ensure that patients are informed about symptoms (particularly pain and knee instability) that might indicate the need for implant review or revision surgery, and the need to seek follow up care should these symptoms arise. For further information please see https://www.tga.gov.au/alert/genesis-ii-knee-system-non-porous-tibial-baseplate-used-knee-replacement. This action has been closed-out on 22/08/2016.

Device

GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate
  • Model / Serial
    GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate Model Number: 71420182 Batch Number: 14CT39993ARTG Number: 207027
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd