| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00893-1 |
| Product Name/Description |
CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner
(components used for Metal on Metal (MoM) Total Hip Arthroplasty)
All implanted lots |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
MicroPort Orthopedics Inc.’s international experience has shown an increasing overall trend in revisions from 2009 to present, and it was identified that there was a specific hazard/harm for “suspected tissue reaction to metal debris”. The potential for a patient reaction when implanted with Metal on Metal THA is a known risk for this product technology. The typical impairment of tissue reaction is reversed by revision surgery to remove the old device and replace it with a new device.
Microport metal on metal total hip replacements have not been used in Australia since 2013 and have been cancelled from the Australian Register of Therapeutic Goods (ARTG). In Australia, published information has shown few users with low revisions. For more information, please see https://www.tga.gov.au/alert/microport-orthopedics-metal-metal-hip-implant-components . |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
MicroPort Orthopedics is contacting surgeons to make them aware of this issue. Rising levels in serial measurements of Cobalt and Chromium in blood, in conjunction with X-ray, MRI and ultrasound can be valuable in the follow-up of patients. Recipients of Total Conventional MoM implants with a large femoral head, and recipients of Total Resurfacing Implants who are female and/or have a small femoral head are at a higher risk of metal pathology related complications leading to revision. These patients should receive particularly close follow-up.
The TGA has developed guidelines for the follow up of patients that have received a MoM hip replacement. These guidelines were developed in consultation with the Australian Orthopaedics Association and The Orthopaedics Sub Committee of the Advisory Committee on the Safety of Medical Devices, and can be found at:
https://www.tga.gov.au/metal-metal-hip-replacement-implants . This action has been closed-out on 07/09/2018. |
| Contact Information |
1300 665 884 - Surgical Specialties |