Finally, five months after issuing an Urgent Safety Notice (USN), DePuy Orthopaedics have issued a recall notice for its ASR Hip acetabular cup (that's the bit that goes on the pelvis side). The USN issued in March of this year advised surgeons that revision rates were significantly higher than should be expected.
Now, in August, the recall notice has been published on the FDA website and states that the company is recalling its ASR 100 and 300 series acetabular hip implant cups sizes 44mm to 70mm
A class action is expected to follow as patients, who have been forced to undergo revision surgery with all that entails, are entitled to compensation.
So what's wrong with the implant?
The implant is metal on metal and as these wear they give off minuscule metal ions which cause inflammation to the surrounding tissue and can loosen the implant. A loose implant is a painful implant and, in most cases, will need to be redone.
There are also concerns about metal ions entering the blood stream.
Once the higher than expected revision rates were noticed DePuy Orthopedics put out the USN and said it would withdraw the implant at the end of the year. I think it is fair to say that some observers couldn't help wondering why they didn't recall it immediately. Instead DePuy send out notices to surgeons reminding them of the need for good patient selection and the proper surgical technique - could that be seen as passing the buck?
DePuy Orthopedics haven't offered an explanation as to why they have waited five months to recall the implant which some surgeons have described as "poorly designed" or "defective".
I'm definitely not the sort that suggests making a claim every time something goes wrong but from what I'm reading in the press it does seem that DePuy could and should have acted sooner. We need to know why they declined to issue the recall notice in March and, importantly, if the grounds were solely commercial - meaning that the company was putting profit before patients health.
Gregg J Borri Law Offices 1-(888)-444-2336 is handling claims for compensation.
Disclaimer - I have absolutely no knowledge of Gregg J Borri Law Offices - their name came up in a press release. There may be other firms handling compensation claims as well
If you've been affected by this recall notice please let us know so that we can all keep an eye on how the situation develops from, the all-important but so often neglected, patient's perspective.