Events

Recall of DePuy Synthes ATTUNE Intuition Distal Femoral Jig

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-2014-RN-01190-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01190-1
  • 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
    Johnson & johnson medical pty ltd (jjm) has identified that the metal pin bushing was incorrectly assembled during the manufacturing process in some instruments. jjm has also determined that if the metal pin bushing is overloaded by over tightening, there is the potential for partial or full displacement of the metal pin bushing along with fracture of the plastic around the metal pin bushing. if the plastic around the metal pin bushing fractures, there is the potential for fragments of the fractured plastic to be left in the patient. this displacement is potentially caused by excessive loading applied during pinning of the jig to the distal femoral condyles. the use of the pins in the distal resection plate is optional and the complaint rate of the bushings partially or fully displacing is 0.018%.
  • Action
    JJM staff will contact hospitals to assist with the inspection and swap of potentially affected units and informing the surgeons that jigs may continue to be used at the discretion of the medical professional following the instructions provided in the letter. JJM is also providing surgeons with a Safety Alert notification to ensure the correct load is applied during pinning of the jig to the distal femoral condyles. This action has been closed-out on 14/07/2016.

Device

DePuy Synthes ATTUNE Intuition Distal Femoral Jig

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia