Events

Recall of DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)

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-00355-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00355-1
  • 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 has identified that there is potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin, for all lots of depuy s-rom noiles rotating hinge femur with pin listed. the outer carton and shrink wrap are intact. the complaint rate for 2010 through 2013 is 0.35%. it is believed that these holes result from repeated shipments of the product in loan kits, over a number of years.
  • Action
    The Operating Room staff/surgeon must be made aware of this potential issue. Prior to implantation, staff must inspect product packaging and if it is identified as having holes in one or both sterile pouches do not use the product and quarantine it. A second set of the DePuy S-ROM Noiles Rotating Hinge Femur with Pin will be sent to each case. S-ROM Noiles Rotating Hinge Femur with Pin devices without packaging breaches may continue to be used to avoid temporarily causing a sudden and complete lack of product availability and the bone loss associated with removing a well-fixed MBT Revision Tibial Tray. This action has been closed-out on 29/01/2016.

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)
  • Model / Serial
    DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421RAll lots numbers affectedARTG 219088
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia