ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient. The ASR artificial hip implant has been linked to a high early failure rate in some patients, according to a letter sent to doctors last week by its maker, DePuy Orthopaedics, a unit of Johnson & Johnson.
In a letter dated March 6, DePuy warned doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient.
According to the letter, patients of small stature, a group that typically includes women and patients with weak bones, faced the highest risk.
The New York Times is reporting that since the beginning of 2008, the the Food and Drug Administration (FDA) has received about 300 complaints on the ASR involving patients in the U.S who received it, the Times said. Most of those patients underwent an operation to have the device replaced soon after getting it.
The warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant
This warning came months after DePuy announce it was phasing out the ASR for declining sales.
According to the Times, the warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant, requiring costly and painful replacement operations. DePuy had already said it would phase out ASR, supposedly for declining sales.
An official with DePuy told the Times some problems with the ASR had arisen because doctors were improperly implanting the device’s cup when first using it. But some doctors believe the ASR – which has a more shallow cup than similar devices – has a design flaw, something DePuy denies.
However, the co-developer of the ASR told the New York Times that he and DePuy officials realized within the last two years that the ASR cup might be more of a challenge to implant properly than competing cups.
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