The Depuy Recall
The DePuy recall has truly shocked the hip replacement world.
Failures in the ASR System
It has been described as "the biggest disaster in the history of orthopaedics" and really it is hard to imagine how something more serious could happen.
The failure of the ASR implant system is horrific in its own right but put together with the company's stubborn refusal to acknowledge the evidence and then later to deny responsiblity for it, moves the entire issue into one of commercial and medical ethics and accountability.
Why medical ethics? Because in 2007 orthopaedic device companies paid out over $114 million to surgeons. One of those companies was Depuy.
Reports from both Australia and the UK showed that about 13% of patients using the ASR system had needed revision surgery within 5 years - some within a few months of their hip surgery. That is approximately twice the expected rate.
Despite this clear evidence DePuy maintained that the device functioned well and that the problems lay with the surgeon, the selection of patient or the patient's negligent care of their new implant.
Who Is Affected?
The Depuy recall will directly affect the lives of 93,000 patients worldwide. But it is not just the people who have had an ASR implant that will be affected. The DePuy hip recall will impact on the lives of everyone that has undergone hip surgery and those on the waiting list.
Most exisiting patients are unaware of the type of implant they have recieved and need to find out quickly. Prospective patients are concerned about the quality of other products and whether this highly rated procedure is still safe because as they read more about the recall they learn of the earlier ones from companies like Zimmer and Styker.
What does the recall include?
The recall only concerns devices used since 2003 and includes the following: -
- ASR acetablular cup (used in both hip resurfacing and hip replacement)
- ASR surface replacement head (only used in hip resurfacing)
- ASR XL femoral head (only used in hip replacement)
Questions That Must Be Answered
There are three main questions that patients and their representatives are asking: -
- Was the device tested fully before being marketed?
- Did DePuy continue selling the products knowing them to be defective?
- Why did it take so long to stop selling and then recall the products after warnings were issued?
Video of Hip Replacement ProblemMedivisuals have produced an animated video showing the problems with Depuy's metal-on-metal implants. It's definitely worth a look.
Both Australia and England & Wales hold registries of all joints implants used in their countries. It was this data that clearly demonstrated the problems with DePuy implants. The Australian Joint Registry, alone issued seven reports to DePuy from 2007.
It is hard to guess how long it would have taken for the problems with the DePuy ASR system to come to light without this type of data.
Since the Depuy recall the USA has now started to set up its own joint registry
Does your country have one? If not, surely it is time it did.