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Recall announced of hip implant device


Medsafe statement, April 13th, 2012


Recall announced of hip implant device

41 New Zealanders who received a MITCH THR hip implant device are being contacted by their surgeons after an international recall of the device.

Data from overseas joint registries indicate there have been higher-than-expected failure rates in the metal-on-metal hip device at the three-year point following implantation.

Dr Stewart Jessamine, Group Manager for Medsafe, says the primary cause of failure is loosening and movement of part of the hip joint replacement.

“As a result of the increased failure rates, patients who have this implant will need to be followed up annually for the life span of the implant. “

“The recall does not mean that patients with the implant will necessarily require revision surgery.”

Stryker, the distributor of the MITCH system in New Zealand, is contacting all surgeons who implanted these devices and asking them to contact their patients who received the MITCH THR implant.

“We are also working closely with the New Zealand Orthopaedic Association and the New Zealand joint registry to ensure people are notified of the recall, given information, and told of the need for further follow-up.”

The New Zealand joint registry reports that three people have had revision (replacement) surgery done in New Zealand due to failure of MITCH components.

The MITCH TRH system is approved in the UK, Europe and Australia amongst other countries.

It was in use in New Zealand between 2006 and 2010 but has not been used since then.

The MITCH system was manufactured by a UK company, Finsbury Orthopaedics Ltd, which was acquired by DePuy Orthopaedics, Inc. in December 2009.

Medsafe recommends that if patients are concerned that they may have a MITCH TRH implant they should contact their doctor or surgeon for further information about the type of implant they have and what follow up, if any is required.

For further information:

The MITCH TRH recall notice:
http://www.medsafe.govt.nz//hot/RecallActionNoticesNew/StrykerMitchHRModularHeadAndacetabularCup.asp

Media statement from MHRA (the UK equivalent of Medsafe):
www.mhra.gov.uk/NewsCentre/Pressreleases/CON149601

MHRA medical device alert notice:
www.mhra.gov.uk/Publications/SafetyWarnings/medicaldevicealerts/CON149600

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