Events

Recall of ADVANCE HA Coated Titanium Tibial Bases, all sizes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Surgical Specialties Pty Ltd.

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-2016-RN-00883-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00883-1
  • 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
    In october 2015, the aoajnrr annual report indicated that the implant was experiencing higher than expected revision rates of 1.37 revisions per 100 observed years. the cumulative percent revision of the implant at 10 years is 11.8% compared to 5.5% for other knee implants. further analysis showed that a large proportion of the revisions (46.9% of revisions, 2.3% of primary procedures) were due to loosening/lysis, and that the advance ha coated tibial base was contributing to the higher rate and therefore microport has decided to remove this device from the market. advance ha coated tibial bases have not been used in australia since 2013 and have been withdrawn from the australian register of therapeutic goods (artg).
  • Action
    MicroPort Orthopaedics Pty Ltd is contacting surgeons to make them aware of this issue with the advice that the likelihood of a patient experiencing a postoperative loosening is very low. Should a patient experience sudden pain, instability, difficulty walking and/or performing common tasks, a tibial loosening can be confirmed via x-ray. A loosened tibial base may require removal through revision surgery. For more details, please see https://www.tga.gov.au/alert/advance-ha-coated-tibial-bases . This action has been closed-out on 24/05/2017.

Device

ADVANCE HA Coated Titanium Tibial Bases, all sizes
  • Model / Serial
    ADVANCE HA Coated TitaniumTibial Bases, all sizesPart Numbers: KTTIHA10, KTTIHA11, KTTIHA20, KTTIHA21, KTTIHA30, KTTIHA31, KTTIHA40, KTTIHA41, KTTIHA50, KTTIHA51, KTTIHA60All Lots
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd