Events

Recall of LCS COMPLETE RPS Knee System

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-2015-RN-00223-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00223-1
  • 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
    Jjm was recently notified by the therapeutic goods administration (tga), that the lcs complete rps knee system has a higher rate of revision than the class of ps knee systems based on recent data from the aoanjrr. after further analysis of the aoanjrr data, depuy orthopaedics, inc (the manufacturer) determined that the lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. the need for a second surgery to resurface the native patella is due to an increased incidence of postoperative patello-femoral pain.
  • Action
    Johnson & Johnson Medical is notifying surgeons of higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. Surgeons are advised that when using the LCS Complete RPS Knee System, the patella must be resurfaced. Johnson & Johnson Medical has also advised surgeons of the potential clinical implications for implanted LCS COMPLETE RPS Knee Systems where the native patella is not resurfaced.For further information https://www.tga.gov.au/alert/lcs-complete-rps-knee-system-used-knee-replacements. This action has been closed-out on 12/08/2016.

Device

LCS COMPLETE RPS Knee System

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes