Tuesday, August 9, 2011

Review of the 2009 Annual report from the National Joint Registry of Australia (part 4 of x)

This is the 4th  post re the joint registry data on the revision history and performance records on the hips.  I specifically was interested in the Depuy Pinnacale as  that is the recommended  option for my revision.

Highlights from the second part of the Australian joint registry report for 2009.

1.  Looks like there are 33 cementless conventional hip revision options reported.  The average revision for those that at least have 5 years of history was approximately 3.4% .

2.  The Depuy Pinnacle hip results:
  • Corail Pinnacle-2.6% @ 5 years
  • S-Rom Pinnacle-3.7% @5 years
  • Summit Pinncale-1.6% @ 5 years
In contrast the Depuy Corail ASR was 5.5% @ 3 years and the Depuy ASR was 5.4 @ 3 years.
    3.  The Pinnacles had average or below average revision rates at 5 years.  That is good news.

    4.  For those hips reported having higher than anticipated revision rates, the Depuy ASR seemed to be under the "newly identified" category in the 2009 report .  This is interesting as the press stated that Depuy had knowledge of these rates for a considerable amount of time prior to this.  Well, if that is true, it was from some other source and not the Australian registry!

    5.  So out of curiosity, I looked at the number and rates of revision for those which were listed under "newly identified"   with higher than anticipated revision rates.  There were 6 devises with an average 3 year revision rate of  5.1%.  The Depuy ASR was 5.4 @ 3 years.  There were two devices at a higher  revision rate than the Depuy ASR.

    6.  There were two other categories of hips with higher than anticipated revision rates:
    • Re-identified and no longer used
      •  9 devices (Combined femoral and acetabular component) in that category with an average
      • 3 year revision rate of  around 10%. 
      • I should note there was one outlier at 33%.  Moving out from 3 to 7 years, the revision rates skyrocket at ranges from 12%-39%!  yikes
    • Re-identifed and still used:
      • 7 devices
      • 4 with data over 3 years
      • 7.75 average revision rate
    2009 Annual Report reported on up to end of 2008 data.

    Total number of devices
    Number of devices with data at 3 years
    Average revision rate at 3 years
    Re- identified and no longer used
    Re identified and still used
    Newly identified

    Here is what I find interesting.  Depuy voluntarily took the ASR off the market in 2010 with a 3 year revision rate of 5.4 according to this report anyway.  Look at category 2 above which have the "re identified and still used hips" and note the revision rate there:  7.75!  I will have to look at the 2010 report to see if those same devices are on the market today.  I will most certainly look at this.

    So, I am quite surprised to see the Depuy ASR on the list for the first time in the 2009 report.  It looks like they certainly reacted to these numbers, albeit not until 2010.  Unless all of the hip parts listed in the "still used" category above are all off the market, it appears that Depuy may have reacted more appropriately than  a number of their peers who have much higher revision rates noted!

    Conclusions above are just a supposition on my part but when you look at the data in context, it seems that the Depuy ASR  revision rates compared to their peers are not as large.  They at least seemed to have reacted while it appears that their peers continue to  have other devices on the market with much higher revision rates.  humm...There is no clear cut number which says:  "remove from the market now" or "remove from the market later." 

    As a former CEO myself, I would have to ask the question:  What is the actual revision rate that would prompt me to remove this device from the market if the following circumstances were the case:
    • I had no studies from my internal folks indicating a problem (big assumption-will leave that to the lawyers to unravel.)
    • My product was just placed on the "newly identified" higher than normal revision rate category for the first time. 
    • Litigation starting but not massive (an event that would have been budgeted for customarily in medical product budgets.)
    There is no clear answer to this question which is why this is in litigation.  One thing is for sure, this is not black and white.  As I said on many prior occasions and I quote my orthopedic surgeon again:  "Its all murky."

    There is  one more item to mention from this report but it is a different subject matter so will post that tomorrow.

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