Events

Recall of SIGMA HP PFJ Cemented Trochlear Implants

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 Synthes.

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-2018-RN-00005-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00005-1
  • 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, depuy orthopaedics, inc. is voluntarily recalling the sigma hp pfj cemented trochlear implants, which is a standalone component of the partial knee system. this decision is based on elevated revision rates observed as part of the company’s post market surveillance process. further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. the company recommends that surgeons use alternative implants or consider a total knee replacement.
  • Action
    DePuy is advising Recipients are requested to return a copy of the completed acknowledgement form as directed in the Hazard Alert and to forward this notice to anyone who needs to be informed. DePuy Orthopaedics, Inc. is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients who received the affected implants.

Device

SIGMA HP PFJ Cemented Trochlear Implants

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes