Medical device giant Zimmer Holdings has removed its Durom Acetabular cup component. Medical device giant Zimmer Holdings has removed its Durom Acetabular cup component from the market in Australia. The device had been used in metal-on-metal hip implants, a class of medical devices that continues to be plagued by negative reports.
MassDevice.com reports Zimmer removed the Durom cup component from the Australian Register of Therapeutic Goods earlier this week. Australian regulators have data showing that the Durom component was associated with a signficantly higher risk of complications compared to other similar devices on the market. At the 7-year mark, 9.6 percent of Durom components required a revision surgery when it was used in a hip resurfacing surgery. The average rate of revision surgeries for other similar devices on the Australian market is just 6.1 percent.
When the Durom components are used in a total hip replacement surgery, the revision rate is 6.8 percent at the 5-year mark. This compares to a revision rate of 3.6 percent for other similar devices.
The announcement that the Durom device was being removed from the market comes a bit late. The MassDevice.com report indicates that use of the Durom components have reduced drastically in recent years in Australia. Since 2005, the device has largely been marginalized and the notification that it has been removed from the Australian market should serve mostly as notification to recipients of these component parts of the increased risk of complications they face.
last known Australian surgery which used a Durom component in a hip implant was in June 2011
The last known Australian surgery which used a Durom component in a hip implant was in June 2011.
This news joins a large number of other reports of widespread complications linked to metal-on-metal hip implants or their component parts. These devices, as a class, appear to increase the risk that a person will suffer a complication soon after they are implanted with one of these devices. Defective overall designs lead to persistent pain and inflammation at the site of an implant. Over time, this pain intensifies and eventually requires a revision surgery, much sooner than was touted prior to a surgery to outfit someone with a metal-on-metal hip implant.
In addition to defective design risks, metal-on-metal hip implants also put recipients at risk of suffering metal poisoning, metallosis, a complication that could have life-threatening or very serious consequences. As the component parts of a metal-on-metal hip implant rub together, like the Zimmer Durom cup, they disperse small metal particles that can accumulate in an implant recipient’s body. This can lead to organ and tissue damage and even the growth of small tumors in their body.