Doctors have warned that this may be just the tip of the iceberg, as the registry figures do not take into account patients who die before having a chance for a second surgery. There are also concerns that doctors are ignoring the pain of many elderly patients with failed knee replacements or that surgery dates are pushed back due to the NHS backlog due to the Covid pandemic.
Even before the pandemic, research from the charity Versus Arthritis shows that between April 2018 and March 2019, 2,400 NHS patients had to wait more than a year for hip or knee replacement surgery.
Problems occur with NexGen devices due to “aseptic loosening” of the tibial component. This is the most common cause of implant failure and means that the component attached to the shin becomes loose, causing pain and swelling as the implant rubs against the bone. This can be debilitating, leaving people in almost constant pain and unable to sleep.
Second riskiest knee replacement
Having a secondary knee replacement is much more important than the initial operation, as it requires removing the old implant and replacing it with a larger device that is surrounded by damaged tissue.
Studies show that revision knee operations take twice as long and carry a higher risk of serious bleeding, infection, and even death. It also prolongs the recovery of the patient.
In 2021, there were 68,974 primary knee replacements and 5,110 revisions in England, Wales and Northern Ireland, according to the register. Of these, 1,909 were caused by aseptic loosening.
This is the latest in a series of joint replacement scandals uncovered by this document. In 2012, The Telegraph revealed how 30,000 patients were at risk from “metal on metal” hip replacements, resulting in toxic metal filings seeping into the patients’ blood.
Dr Alison Cave, MHRA Director of Safety, said: “We are actively working with relevant stakeholders and reviewing all available evidence from a variety of sources on the concerns raised about the performance of the NexGen knee implant. We will take appropriate security measures if necessary.
“If you are experiencing pain or other issues associated with NexGen knee implants, please speak with your implanting surgeon.”
‘Bad timing for overstretched NHS’
A statement from Zimmer Biomet read: “Zimmer Biomet is committed to patient safety and we take product quality very seriously. We are conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the higher overall revision rates when these tibial components are used with the LPS Flex or LPS Flex GSF Femoral Components compared to other total knee arthroplasties in the United States. National Joint Registry of the Kingdom.
“The LPS Flex and LPS Flex GSF femoral components are not being recalled. We are working closely with regulatory authorities on this voluntary recall and information will be sent to surgeons advising them of the details regarding this recall next week. At that time, the information will also be available on our website.”
Dr. Benjamin Ellis, Senior Clinical Policy Advisor at Versus Arthritis and consultant rheumatologist, said: “Many people with arthritis will read about these faulty implants with concern, wondering how an unreliable product was allowed to be given to perhaps 10,000 people who are now potentially face the prospect of needing a repeat operation.
“This couldn’t come at a worse time for the overburdened NHS with hundreds of thousands of people already facing unacceptably long waits for joint replacement surgery.”