Emma Hall comments on voluntary recall of Zimmer Biomet's NexGen knee implants

Following reports that the UK health regulator, the MHRA (Medicines and Healthcare products Regulatory Agency) is preparing to issue a field safety notice prohibiting the use of the faulty knee replacements, the concern of course is that the problem is far more widespread than originally considered.

Thus far, it is recorded that 10,000 patients have been given the faulty knee implants, doubling their risk of joint failure. The statistics show that the implant has been shown to fail in up to 7 per cent of patients after 10 years, twice the accepted failure rate of 3.5 per cent set by the National Joint Registry.

What this means is that those poor patients will likely have to undergo additional knee replacement surgery, which poses a much greater risk since it requires removing the previous implant and replacing it with a larger device, which is surrounded by damaged tissue. Knee revision operations take twice as long and carry an increased risk of severe bleeding, infection and even death and patient recovery is much longer.

And this is on top of the agonising problems the faulty NexGen devices will already have caused those patients, due to 'aseptic loosening' of the tibial component – that is, the part attached to the shin comes loose, causing inflammation and pain as the implant rubs against bone, creating severe and debilitating pain from which there is little relief.

Zimmer Biomet, the manufacturer of the implant, has withdrawn the product from the market, and have confirmed that they will be issuing a voluntary medical device recall and field safety notice prohibiting use of the NexGen Stemmed Option Tibial Components because of the high number of revisions associated with its use.

But what concerns doctors is that the problem might be far more widespread than recorded because elderly people - more likely to have undergone knee replacement surgery – may have died before the fault was noticed, or are not listened to when they complain about discomfort. 

In a product liability situation such as this, those affected also may only come forward and report a problem once they learn that other people have experienced similar symptoms.

Having worked previously on similar group actions involving product liability and faulty medical devices, I am always happy to speak to people on the phone to discuss their situation and to advise whether they likely have a claim against the manufacturer of a faulty product for the injury, pain and suffering associated with it.

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