Total (hip) recall

September 1, 2010
By: Vicki Bell

Last week I wrote about a problem I encountered when trying to get my eyeglasses repaired — the lenses would not fit the identical replacement frames, because these frames are made in China, and each batch is different. This is just one example of the enormous quality issue surrounding Chinese-made goods. But compared to what happened late last week, it was a minor inconvenience to me … a passing gnat. You see, I'm the proud owner of a DePuy (Johnson and Johnson) ASR XL Acetabular System, one of 93,000 units that have been recalled.

The ASR XL isn't a vehicle with a sticky accelerator pedal, but it definitely is something that has enhanced my speed since I acquired it in 2008. It's a hip implant that — up until last week — I thought was a sterling example of bionics at its best. Now I'm worried that the device is in my body, possibly breaking down and releasing metals into my bloodstream. 

When I read the news about the recall, I did what many other hip implant patients undoubtedly did — called my orthopedic surgeon's office. It was late on Friday when I left my message with his nurse, and I really didn't expect a call back until after the weekend. I was surprised to receive one that evening. The nurse — the same nurse who's been with my surgeon since I first consulted him in 2003, which I find comforting — said she was returning all calls about the implants, because she was afraid "patients would freak over the weekend." She then began to go over my records.

Here's the scoop: I had one hip replaced in 2004 with a device that has a metal stem and a composite ball. The surgeon chose this implant specifically because at that time there was no suitable device with a large metal ball. Now six years old, this hip continues to function great. I have had zero problems with it. It is not an ASR XL. 

In 2008, I had the second hip done. The surgeon was delighted to be able to implant an all metal device with a large ball. I have had no problems with it, other than a continuous slight pressure on the outside of my leg. This implant is an ASR XL. 

I trust my orthopedic surgeon with my life, literally. He did an amazing job with both operations. I spent only one night in the hospital each time and had problem-free, speedy recoveries. Although I was not scheduled to see him again until next year, I soon will be sitting in his examining room looking at x-rays and having blood drawn. This process will continue until I die, or until the device has to be replaced, whichever comes first. 

As DePuy announced on its Web site, it is voluntarily recalling the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System because of the number of patients who required a second hip replacement procedure, called a revision surgery. 

New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12 percent for the ASR  Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System.  These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter (check) and among female patients (check). 

Now, I'm optimistic and believe that I probably will fall in the 87 percentile of patients who will have no problems. Optimistic, but not stupid. I will continue my checkups and trust my surgeon.  DePuy recommends yearly monitoring "to ensure the ASR hip replacement is functioning well, even in the absence of symptoms." 

Already the lawsuits have begun. Every manufacturer's nightmare. But as ukjawdoc wrote to another Vicki(e) earlier this year on, the failure of these implants might not lie solely with the manufacturer. 

Check back for an update after I meet with my surgeon, who is waiting for information from DePuy about where to send blood samples and who's paying for what. This could take awhile.

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Vicki Bell

Vicki Bell

FMA Communications Inc.
2135 Point Blvd
Elgin, IL 60123
Phone: 815-227-8209