Events

Recall of Acor and Integrale primary femoral stem with modular neck

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Amplitude Australia 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-2017-RN-00497-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00497-1
  • 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
    Amplitude would like to emphasize that patient selection is a key factor for the primary or revision implantation of the acor and integrale primary femoral stem with modular neck systems. patients with both a large lever arm and a heavy weight often cause severe stress on the modular joint.Reports of femoral neck fractures for certain combinations of modular necks and femoral heads have been received by the manufacturer, amplitude. subsequently, additional mechanical tests determining the fatigue strength of the proximal stem geometry have been conducted on the modular neck stems according to the recent standard iso 7206 -6: 2013 in order to determine which combinations of necks and heads should be subjected to usage restrictions.The surgical technique and the ifu have been updated with these usage restrictions regarding combination bans and admissible patient weight limits.
  • Action
    Neosurgical is updating the IFU and Surgical Technique to highlight to surgeons the importance of observing the head/neck combination restrictions when using the device. Users are also advised to report any adverse reactions observed with the devices to Amplitude and/or to the Therapeutic Goods Administration (TGA).

Device

Acor and Integrale primary femoral stem with modular neck
  • Model / Serial
    Acor and Integrale primary femoral stem with modular neckReference Numbers: 1-0106701, 1-0106702, 1-0106703, 1-0106704, 1-0191001, 1-0191002, 1-0191003 and 1-0191004Certificate Number: DV-2013-MC-04752-1ARTG Number: 210537
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd