Events

Recall of LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component (internal femoral component)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

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-00735-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00735-1
  • 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 lps lower extremity dovetail intercalary component has the potential for the female component to fracture when exposed to certain physiological loads.
  • Action
    Johnson & Johnson Medical is not recommending prophylactic treatment in the absence of symptoms. Surgeons are recommended to review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors. If a patient presents with a fractured LPS Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines that the LPS Lower Extremity Dovetail Intercalary component is the best treatment option, the company will make the LPS Lower Extremity Dovetail Intercalary component available. For more details, please see http://www.tga.gov.au/safety/alerts-device-limb-preservation-system-130805.htm .

Device

LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component (internal femoral c...

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia