Published: 16 April 2012
16 April 2012
Medsafe is providing the following information to patients, healthcare professionals, and the media about Stryker MITCH hip implants.
Reports from national joint registries in the United Kingdom and Australia confirm that use of the MITCH TRH modular head/acetabular cup in combination with the Accolade femoral stem results in significantly higher revision rates than seen for all other total hip prosthesis. As a result of these findings, Stryker has cancelled the WAND entry and will no longer supply the Mitch TRH modular head in the New Zealand market.
Stryker have issued a letter to surgeons to inform them of this hazard alert and advise them to contact all of their patients who have the MITCH TRH modular head implanted (estimated to be 50 patients).
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 MITCH TRH acetabular components should be followed up more frequently than normal.
Medsafe, Ministry of Health, has made a media release about the recall notice (hazard alert) issued by
Stryker NZ Ltd concerning the Stryker MITCH Hip Implant devices.
Link to the Media Release
Link to the Stryker Hazard Alert (Adobe PDF document, 12 KB)
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.
