Advance HA coated tibial bases

Hazard alert - potential for implant failure due to loosening

20 November 2016

Consumers and health professionals are advised that Microport Orthopaedics, in consultation with the TGA, is issuing a hazard alert regarding a higher-than-expected revision rate for its Advance HA coated tibial bases.

Advance HA coated tibial bases

Advance HA coated tibial bases are a component used in total knee replacements.

In October 2015 the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) Annual Report indicated that the implant was experiencing higher-than-expected revision rates. Further analysis showed that a large proportion of the revisions were due to loosening.

A loosened tibial base may require removal through revision surgery.

Advance HA coated tibial bases have not been used in Australia since 2013 and have been withdrawn from the Australian Register of Therapeutic Goods.

Information for consumers

If you or someone you provide care for has received an implant using an Advance HA coated tibial base, be aware of this issue. Microport Orthopaedics advises that the likelihood of loosening after surgery is low.

If you are not sure what type of knee replacement you have or if you have concerns about your knee replacement, you should seek information from the orthopaedic surgeon who performed the operation or the hospital where the operation was performed.

Contact your general practitioner/surgeon if you experience any of the following symptoms relating to your knee replacement:

  • pain
  • swelling
  • instability
  • difficulty walking.

Information for health professionals

If you are treating someone who has received an implant using an Advance HA coated tibial base, be aware of this issue.

Patients with any knee replacement should be followed up by the implanting surgeon if they complain of pain, swelling or instability in their knee.

Information for orthopaedic surgeons

MicroPort Orthopedics is contacting surgeons who have used Advance HA coated tibial bases to make them aware of this issue.

In October 2015 the AOANJRR 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 was 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. Following this finding, Microport decided to remove this device from the market.

Should a patient experience sudden pain, instability, difficulty walking and/or performing common tasks, potential tibial loosening can be confirmed via x-ray.

Microport Orthopaedics advises surgeons to inform patients that the likelihood of postoperative loosening is low.

If you have any questions or concerns relating to this issue, contact the Australian sponsor, Surgical Specialities by phone on 1300 665 884.

Affected products
Part Number Descriptions
KTTIHA10 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 1
KTTIHA11 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 1+
KTTIHA20 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 2
KTTIHA21 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 2+
KTTIHA30 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 3
KTTIHA31 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 3+
KTTIHA40 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 4
KTTIHA41 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 4+
KTTIHA50 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 5
KTTIHA51 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 5+
KTTIHA60 ADVANCE HA COATED TITANIUM TIBIAL BASE SIZE 6

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.