Hip replacement recall1st September 2010
UK hospitals have been issued a warning over hip replacement devices.
The alert comes from medical device company DePuy Orthopaedics, which is a subsidiary of Johnson and Johnson, and has issued an urgent safety notice after discovering problems with hip replacement devices thought to have been fitted in hundreds of NHS patients.
The company has warned UK hospitals not to implant any further devices and to recall any patients implanted with the devices for checks.
The voluntary product recall and instruction to review all patients follows fresh evidence that patients implanted with the hip resurfacing and full replacement devices have needed replacement surgery at more than twice the expected rate.
Data from the UK National Joint Registry – yet to be published – is understood to show that on average 12-13% of patients implanted with DePuy’s devices for metal-on-metal total hip replacements and resurfacing procedures needed to have their operation repeated within five years. The generally accepted rate is less than 5% after five years.
A letter from DePuy’s vice president for worldwide clinical affairs, Pamela Plouhar, raises concerns that some patients may develop progressive soft tissue reactions from metal debris resulting from the device.
While unable to confirm how many people in the UK had been fitted with the device, DePuy said it believed that worldwide some 93,000 patients had an affected implant.
However, 257 clinical centres in the UK used the affected devices.
DePuy has said it intends to cover reasonable and customary costs for monitoring and treating affected patients.
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Wednesday 29th September 2010 @ 20:10
Evidence suggests that this move has been necessary for quite some time now. The UK study you mention seems to be the proverbial straw that broke DePuy’s back, but the US Food and Drug Administration (FDA) has been receiving complaints about the device since it was made available here in 2005. There were more than 300 in 2009 alone. Still, DePuy did not issue a recall until the data released by the Joint Registry of England and Wales showed a 12-13 percent revision rate. One has to wonder when the recall would have been issued (or if it would have been issued at all) were it not for this new data.
Friday 5th November 2010 @ 20:58
I had to have a revision because of this products failure. I've heard that it should have been recalled when Australia's Joint Registry established that there was a fault. Australia recalled it in December 2009 so even if you take it that they knew then, that was still 10 months before they recalled the ASR product in the UK - how many patients had it fitted in that time? Disgusting. I have a lawyer on the case and Johnson and Johnson pretty much bang to rights I'm told.
Sunday 6th March 2011 @ 19:19
hi, i had a MOM hip resurfacement 5 years ago and i ve been taking painkillers ever since, i have not been recalled to the hospital, but my GP sent me to hospital, i ve had blood tests and a scan, blood test revealed colbalt 629 and chromium 333 which the consultant said is high. They have now decided to send me to Wrightington Hospital for a second opinion,
Sunday 1st May 2011 @ 14:17
I had a hip resurfacing at wrightington 6 years ago and the hospital recalled me in feb 2011 for a checkup and blood test. My results were cobalt 2 chromium 2.2 which they said was ok. My other hip is causing me some pain and I am under hope hospital for that one as I wasnt impressed with the care at wrightington. This other hip will not last me much longer but my resurfaced hip has started to ache me a bit recently, probably because im leaning on it more because of my other hip is going. Im not sure what to do for the best have my painful one done first incase my other doesnt last me much longer and do i have a case against the manufacturers.
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Title: Hip replacement recall
Author: Mark Nicholls
Article Id: 15946
Date Added: 1st Sep 2010