The MHRA has received reports of higher than anticipated rates of revision for ASRTM acetabular cups.
| Medical Device Alert: DePuy ASR acetabular cups used in hip resurfacing arthroplasty and total hip r |
Medical Device Alert: DePuy ASR acetabular cups used in hip resurfacing arthroplasty and total hip replacementSubsequent to the publication of the MHRA’s Medical Device Alert MDA/2010/033 for metal-on-metal hip replacements on 22 April 2010, the National Joint Registry (NJR) of England and Wales informed the MHRA that ASRTM acetabular cups had been identified from registry data as having higher than anticipated rates of revision in hip resurfacing and total hip replacement procedures (see Appendix). The MHRA has also received similar reports from two of the 257 clinical centres in the UK that have implanted these devices.
All users were informed of correct cup angles in the manufacturer’s Field Safety Notice of 8 March 2010. The FSN did not recommend any additional follow-up for patients in the absence of symptoms. However, the performance of devices implanted outside the manufacturer’s currently recommended angle range (40º– 45º) is not known. DePuy ASRTM acetabular cups have been in clinical use in the UK since 2003. Source: http://www.orthospinenews.com/medical-device-alert-depuy-asr-acetabular-cups-used-in-hip-resurfacing-arthroplasty-and-total-hip-replacement
To monitor whether or not a DePuy ASR Recall has occurred or not, please click the link to visit the page. If you or a loved one has been implanted with a DePuy ASR System and required revision surgery or other complications please contact us for a free claim evaluation.
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DePuy produces two different instruction documents for this device:
the
instructions for use (IFU) supplied with the device, and the surgical
technique
manual. A cup inclination angle of 45º is recommended for reaming and
implantation in all versions of the surgical technique manual. However,
the
original IFU did not contain reference to specific cup placement angles.
Based
on post-market experience, in October 2008, the manufacturer added
to its IFU
(Revision C) a recommended cup inclination angle of between 40º and 45º
and
distributed a document entitled ‘The importance of correct acetabular
component
positioning’ highlighting the importance of cup angles to implanting
surgeons
from February 2009.
