At least 10,000 patients received knee-replacements using a “failing” implant, an investigation has revealed.
NHS England has launched a probe after those fitted with the NexGen knee implant told how they were left immobile and forced to down industrial strength painkillers while medics who carried out procedures had their competency questioned.
Surgeons claim US manufacturer Zimmer Biomet took too long to acknowledge there was a problem with one particular component known to have a concerning failure rate eight years before it was finally withdrawn.
Debbie Booker from Southampton went under the knife to replace her left knee in 2016 but experienced excruciating pain a year later from the implant slipping from the tibia and wearing away the bone.
She said: “I laid a bag of ice on my knee and for four days I had to do that every few hours because I was in agony.
“I was on fentanyl and morphine. It took me a long time to come off of the morphine because I was addicted.”
She has since had a second knee replacement, but the problems caused by the initial failed implant means she walks with a limp and is on the waiting list for a hip replacement.
Another patient, who asked to remain anonymous, had a knee implant fitted in 2021 which also slipped and started to wear away her shin bone, leaving her practically immobile.
She said: “The consultant told me every time I stood up, I was standing on a broken leg. It was absolute agony.”
The size and scale of the crisis was revealed in an investigation by BBC Radio 4.
As part of her surgery Mrs Booker received a specific implant section known as a “stemmed option tibial component”, or” tibial tray”, but it lacked a layer of plastic contained in earlier versions of the NexGen replacement knee.
Zimmer Biomet started marketing this modified version in 2012. In the following decade, more than 10,000 patients were fitted with this version of the implant.
All have been recalled for a review by the hospitals where they had their initial operations. Hundreds have been force to have a second operation.
File on 4 Investigates: My Faulty Knee Replacement found concerns were first flagged in 2014 by the National Joint Registry which records implant surgery across England, Wales and Northern Ireland.
In 2022 it estimated patients were nearly twice as likely to need corrective surgery after receiving the NexGen implant, when compared with the average knee implant. In the same year Zimmer Biomet recalled any unused implants from the UK market.
Each year in the UK more than 100,000 knee replacement operation are carried out on patients with an average age of 69. The majority are for osteoarthritis.
The procedure involves removing damaged surfaces of the femur (thigh bone) and the tibia (shin bone) and replacing them with artificial components.
Zimmer Biomet said patient safety is its “top priority” and its products are approved in accordance with the relevant regulations.
The company said: “Zimmer Biomet is committed to the highest standards of patient safety, quality, and transparency. When new data becomes available, we act appropriately, responsibly, and in accordance with applicable regulatory requirements.”
NHS England said: “The safety of patients is the absolute priority for the NHS.
“Where issues are identified with any medical device, local NHS teams work swiftly to assess patients and provide replacement treatment where clinically necessary, in accordance with recommendations from the MHRA and device manufacturers.
“NHS England is currently reviewing the case involving Zimmer Biomet NexGen knee implants.”
