Monday, August 15, 2011

Review of the 2010 Australian Joint Registry Results for hips having higher than anticipated revision rates(2 of x)

Findings.

(1)  There are 3 categories of conventional hips identified has having a higher than anticipated revision rate:

  • Identified and no longer used
  • Re-identified and STILL USED
  • Newly identified
(2)  These hip parts have revision rates with the following averages per category:


1 year

3 years

5 years

7 years

 9 years

Identified and no longer used
3.72%
(13 devices)
9.3%
(13 devices)
13.4%
(12 devices)
17.95
(9 devices)
18.85%
(2 devices)
Re-identified* and still used
3.6%
(8 devices)
6.2%
(6 devices)
7.6%
(4 devices)
---------
--------
Newly identified
3.55%
(6 devices)
5.7%
(3 devices)
5.8%
(1 device)
6.9%
(1 device)
-----
Depuy ASR acetabular component*
1.8%
5.9%
9.3%



* Depuy ASR MoM hip has since been recalled but I showed it as its own line to give you a sense of the other devices still on the market with similar or worse revision rates!

(3)  The ranges of these revisions is quite high.  The highest revision rate by year post surgery:

  • 1 year: 12.1%
  • 3 years: 33%
  • 5 years: 39%
  • 7years: 39%
  • 9 years: 25%
(4)   Under the re-identified and still used and newly identified components from 2009-2010 reports:
  • Profemur Z
  • Bionik
  • ASR
  • Esop/Atlas
  • ML Taper/fitmore
  • Alloclassic/Duron
There is no magic recall rate but it is very clear that there are boundaries in which "acceptable" revision rates are bounded.  Depuy was getting quite close to an unacceptable boundary as far as I can tell.  How proactive were they based on these averages?  Well, they likely could have left this hip on the market another few years based on their revision  rates but that would have been pushing the envelope.

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