Almost a year ago (August 2010), DePuy Orthopaedics Inc. announced that it was recalling their ASR hip replacement systems due to a “higher than expected” failure rate. However, no DePuy Pinnacle recall was announced – this system being an almost identical metal-on-metal hip replacement system – despite similar injuries being sustained by patients who have received the alternative hip replacement system.
Only Minute Differences Between the Two Systems
The only possible reason for the lack of a DePuy Pinnacle recall is that minute differences exist between the recalled ASR hip replacement systems and the DePuy Pinnacle hip replacement system. However, arguments that the DePuy Pinnacle system has a modular design and a separate outer shell (whereas the ASR was of a monoblock design – i.e. a solid piece of metal) are outweighed by the fact that the DePuy Pinnacle device has one of the lowest articulation clearance levels in the industry. In fact, the only one lower is the DePuy ASR system!
Is This Enough For a DePuy Pinnacle Hip Replacement Recall?
Although the DePuy Pinnacle Hip Replacement system was only introduced in March 2008 (the ASR devices were introduced from 2003) doctors in the USA are already reporting the failure of the devices and the need for revision surgery. If this was not alarming enough, it was also revealed that the DePuy Pinnacle Hip Replacement system bypassed the USA´s Food and Drug Administration testing procedure by showing that the device was similar to those already in existence on the market. Known as the 501(k) process, DePuy got their Pinnacle Hip Replacement system on the market by showing it was similar to the ASR Hip Replacement systems!
No News is Bad News!
Quite possible a DePuy Pinnacle recall will only be made once the company has received a substantial number of failure reports, but in the same way as DePuy Orthopaedics failed to advise surgeons and medical practitioners about the failure rate of the ASR systems, there is a deafening silence in response to allegations that the DePuy Pinnacle system is also faulty. One would expect that the duplication of the injuries experienced by patients who received the DePuy ASR Hip Replacement systems should be enough to instigate a DePuy Pinnacle recall but, as yet, there is no sign of this happening.
Could the HSE Initiate a DePuy Pinnacle Recall?
The Health Services Executive (HSE) has already come under a lot of criticism for continuing to implant ASR Hip Replacement systems when indications from across the globe suggested that the devices were faulty. They also played down the consequences for patients who needed revision surgery – both in number and effect – and supported the DePuy Patient Consent Form process which potentially removed the right of victims to claim compensation.
Even if the company fail to initiate a DePuy Pinnacle Hip Replacement recall, surely the HSE should look at the reports coming in from surgeons all over the country showing that history is repeating itself so soon, and take positive action. The symptoms that caused the recall of the ASR devices are appearing once again in the DePuy Pinnacle devices, and it is time for a DePuy Pinnacle Hip Replacement Recall in Ireland.
DePuy Hip Replacement Recall – Further Information
If you have been implanted with either the DePuy ASR or DePuy Pinnacle Hip Replacement systems, and are concerned that they may be faulty, please read our comprehensive article by clicking here. Thereafter, should you have any medical concerns about your condition, please make an urgent appointment to see your family GP. If you have any legal questions about your entitlement to claim compensation you are invited to call us on 1-800 848 881.