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Patient urges implant recall | Otago Daily Times Online News : Otago, South Island, New Zealand & International News.

By Eileen Goodwin on Sun, 22 Apr 2012

Dunedin man Ken Burt is awaiting a second operation to correct a troublesome articifical hip. Photo by Gerard O'Brien.Dunedin man Ken Burt is awaiting a second operation to correct a troublesome articifical hip. Photo by Gerard O’Brien.

A Dunedin man whose metal-on-metal hip implant was removed after an adverse reaction says the implant should be recalled.

Ken Burt (57) is waiting for a second operation to correct pain and discomfort arising from a March 2008 operation when he was fitted with a Johnson and Johnson DePuy metal-on-metal Pinnacle implant.

In 2010, the titanium ball and liner were replaced with ceramic equivalents, and the surgeon found the site was infected.

The surgeon had to cut out tissue and clean the site.

“It looked like blue vein cheese inside there.”

Now, Mr Burt faced a “blind operation”, as the surgeon did not know what he would find.

“It could be as easy as opening it up and cleaning it out, to losing the hip completely.”

The ACC accepted his claim as a treatment injury, caused by an abnormal reaction. It said in a letter to Mr Burt the reaction was probably caused by excess wear, possibly a result of a minor misalignment, which Mr Burt rejects.

However, the ACC and Dunedin Hospital had been “fantastic” when dealing with his case.

The situation improved for a while after the 2010 operation, but he again suffered pain and limited mobility, caused by toxicity from the original implant, he said.

“They reckon once that stuff gets in your system, it can take ages to get rid of it.”

He believed the implant had the same flaw as metal-on-metal implants that had been recalled.

New Zealand’s Medsafe recalled DePuy’s ASR joint in 2010, and the Stryker Mitch TRH last week. Johnson and Johnson owns DePuy.

Recalls did not mean implants had to be removed, but their recipients would be closely monitored and advised.

New Zealand Orthopaedic Association chief executive Flora Gilkinson said Pinnacle implants were not “featuring” in current concerns about metal-on-metal implants.

While any implant could cause a reaction, she did not believe there was a particular issue with Pinnacle.

The joint registry indicated 1060 New Zealanders had received an implant similar to Mr Burt’s.

In a statement to the Otago Daily Times this week, medical safety regulator Medsafe said there was no evidence of a higher-than acceptable failure rate for Pinnacle.

“Medsafe will be following international developments in relation to metal-on-metal implants as more information becomes available through the intensified scrutiny to which they are now being subjected,” Medsafe principal regulation adviser Susan Martindale said.

Medsafe’s information web page dealing with metal-on-metal hip implants links to a February British Medical Journal feature by investigations editor Deborah Cohen. The feature highlights increased metal ion levels linked to Pinnacle and other metal-on-metal implants.

The feature said Pinnacle, DePuy’s “flagship” implant, was promoted more strongly after the ASR recall in 2010.

A Johnson and Johnson spokeswoman told the ODT more than a decade of worldwide clinical and registry data had consistently shown the Pinnacle system to be safe and effective.

“DePuy’s first priority is for the care and wellbeing of all patients and we encourage any patients who have questions regarding their hip implant to contact their surgeon,” she said.

– eileen.goodwin@odt.co.nz

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