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Smith and Nephew hip implant recalled worldwide


Medsafe statement, 8 June 2012

Smith and Nephew hip implant recalled worldwide

A hip implant with a metal liner is being recalled in New Zealand and worldwide by its overseas manufacturer.

Smith and Nephew, a UK company, says its R3 hip implant metal liner is not performing as well as desired.

139 of the implants have been supplied to New Zealand.

70,889 hip implants have been carried out in New Zealand in the past 11 years - of those 6,225 have been metal-on-metal implants.

In New Zealand, the number of metal-on-metal implant devices recalled has been 525 for the ASR, 41 for the Mitch implant, and 139 for the Smith and Nephew.

Medsafe, New Zealand medicines and medical device regulator, says Smith and Nephew are contacting surgeons to alert them of the recall, ask them to contact affected patients, and advise them of the need for greater monitoring of their patients.

Derek Fitzgerald, Medsafe Head of Compliance Management, says many patients with these implants and other metal-on-metal implants will not be affected by this problem.

“The recall does not mean patients with the implant will necessarily require revision surgery however as a precaution patients with this implant will be followed up more frequently by their doctor.

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

This recall is the third worldwide of a metal-on-metal implant, with the De Puy ASR recall in 2010, and the Mitch TR implant earlier this year.

The three recalls of metal-on-metal hip implants represent less than 1 per cent of the hip replacements done in this country in the past 11 years.

Medsafe will follow-up with the manufacturers to ensure specialists have been contacted and patients notified.

For further information, contact senior communications advisor Kevin McCarthy, 021 832 459.

Background

The Smith and Nephew R3 metal liners were first used in Europe and Australia in 2007, NZ in 2008 and globally from 2009.

A liner is the bearing surface, or cup, that the head of an artificial hip rotates in. The surfaces can be constructed of metal, ceramics and plastics.

Smith and Nephew have recalled the product as the United Kingdom and Australian joint registries are both reporting the metal liners are having higher revision rates than for R3 implants that use other liners.

There is a heightened awareness worldwide of possible higher revision rates in such devices. The risk to patients is from localised tissue damage.

Information about joint implants and revisions is collected by a register run by the New Zealand Orthopaedic Association.

Information for consumers about metal-on-metal implants has been published on the Medsafe website, and made available to surgeons here:

http://www.medsafe.govt.nz/hot/RecallActionNoticesNew/MetalOnMetalHipImplants/MetalonMetalHipImplantsFAQ.asp

ENDS

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