Published: 7 June 2012
Safety Information
Smith & Nephew R3 Hip Implants Metal Liner
7 June 2012
Medsafe is providing the following information to patients, healthcare professionals, and the media about Smith & Nephew R3 hip implants with metal liners.
Reports from national joint registries in the United Kingdom and Australia confirm that the metal liner of the Smith & Nephew R3 Hip implants have higher replacement (revision) rates than seen for the liners manufactured from polyethylene. As a result of these findings, Smith & Nephew is recalling unimplanted stock of R3 metal liners from the New Zealand market.
This recall does not impact on the Smith & Nephew R3 polyethylene or BIOLOX Delta (ceramic) liners.
Smith & Nephew has issued a letter to surgeons to inform them of this hazard alert which includes a request for them to contact all of their patients who have the Smith & Nephew R3 metal liners implanted (estimated to be 139 devices).
In line with international guidelines such as those published by the MHRA for patients with metal on metal hip replacements it is recommended that patients who have total conventional hip replacements with Smith & Nephew R3 metal liners should be followed up more frequently than normal.
Media Release
Medsafe, Ministry of Health, has made a media release about the recall
notice (hazard alert) issued by Smith & Nephew Surgical NZ Ltd concerning
the R3 metal liner.
Link
to the Media Release
Smith & Nephew Hazard Alert
Link to the Smith & Nephew Hazard Alert (Adobe PDF document, 264 kB)
Links to more information
Link to Questions and Answers about Metal-on-Metal Hip Implants on the Medsafe website.
External link to Smith & Nephew R3 website about this recall action
External link to New Zealand Orthopaedics Association website information about Metal-on-Metal hip implants (Microsoft Word document 25 kB)
Management of Patients with Metal-on-Metal Hip Implants
Medsafe and the New Zealand Orthopaedic Association (NZOA) (www.NZOA.org.nz) support the advice to healthcare professionals issued by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the management of patients implanted with metal on metal hip replacements.
