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Hazard alert - Durom Acetabular Cup

October 26, 2012

Hazard alert - Durom Acetabular Cup

Surgeons in New Zealand have been asked some months ago to carry out annual monitoring of all patients with metal-on-metal hip implants following alerts some devices need to be replaced earlier than expected.

Medsafe have been advised the Durom Acetabular Cup, a device no longer being used in New Zealand, is subject to an international hazard alert.

The New Zealand Joint Registry reports the device, which was discontinued by its manufacturer in June 2011, was used in 252 hip implants in New Zealand.

Medsafe Group Manager Dr Stewart Jessamine says patient health is not at risk – some people will simply require their implant to be replaced earlier than expected.

“On average 90 per cent of people with a metal on metal hip implant will have no problems with their implant at 10 years – a revision rate of 1.00 per 100 component years.

“For the Durom device around 84 per cent of patients will not have problems at 10 years. The slightly higher revision rate of 1.68 per 100 component years is the reason why the product is being recalled. They do not pose any additional health risk to patients.

“There is a greater awareness by manufacturers and regulators about these devices, which is why we are seeing more of these alerts, say Dr Jessamine.

“Regulators around the world, including Australia, have responded in a similar way as Medsafe to the finding that some hip device products have higher revision rates.



Medsafe will continue to work with manufacturers to ensure that when an alert is issued, surgeons are fully informed and follow up with their patients.

“If patients have any concerns or experience any discomfort or pain, they should see their GP or surgeon, as they normally would following any surgery on a joint."

Metal-on-metal implants have been used in around 8% of the total hip implants during the last decade and this rate is declining.


Information for consumers about metal-on-metal implants has been published on the Medsafe website at: http://www.medsafe.govt.nz/profs/device-issues.asp#17April2012 and made available to surgeons.

ADDITIONAL INFORMATION:

This component was first used in New Zealand in 2003, but discontinued as a product by its manufacturer in June 2011.

Information about joint implants and revisions is collected by a register run by the New Zealand Orthopaedic Association: http://www.nzoa.org.nz

This is the fifth action in New Zealand relating to the use of metal-on-metal implant components, starting with De Puy ASR in 2010 (525 devices in New Zealand), and earlier in this year, the Mitch TR (41), the Smith and Nephew R3 (139) and the Birmingham Hip Modular Head (396).

ENDS

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