What’s the deal with this option tibia recall via the UK registry?
Why?
Why?
Nexgen recall
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10,000 patients affected ….NHS recall
Read the UK JBJS report …
Read the UK JBJS report …
The Nexgen product was voluntarily recalled by the manufacturer thus far. Zimmer Biomet, in October this year after concerns that the components were failing at an unacceptably high rate. The Nexgen is the second most commonly used brand of knee replacement used in the UK, and is frequently recommended by NHS surgeons carrying out knee replacements.
Concerns from operating surgeons are reported in the medical literature, with one study in particular noting a 17.6% failure rate at 5 years post-implantation. Concerns mostly arise from loosening of the tibial component, which connects to the bone in the lower leg.
The MHRA can issue a Field Safety Notice, which prohibits an unsafe product from being used in the UK. They are expected to make an announcement soon once their initial investigations are concluded.
This knee replacement product was very widely used and trusted by many patients and surgeons, with tens of thousands of people in the UK having been implanted with it. The reports of failure rates above 15% are deeply concerning for patients, and should prompt the MHRA to carry out a thorough assessment of whether the Nexgen is safe for patients.
Concerns from operating surgeons are reported in the medical literature, with one study in particular noting a 17.6% failure rate at 5 years post-implantation. Concerns mostly arise from loosening of the tibial component, which connects to the bone in the lower leg.
The MHRA can issue a Field Safety Notice, which prohibits an unsafe product from being used in the UK. They are expected to make an announcement soon once their initial investigations are concluded.
This knee replacement product was very widely used and trusted by many patients and surgeons, with tens of thousands of people in the UK having been implanted with it. The reports of failure rates above 15% are deeply concerning for patients, and should prompt the MHRA to carry out a thorough assessment of whether the Nexgen is safe for patients.
Great…. My surgeon was asking me about this yesterday and I didn’t know what to say. Sounds like word is spreading….. what are we supposed to say? The uk registry is a smaller sample? I mean, who here doesn’t revise baseplates rather frequently?
Crickets???? Really. Why is everyone so quite now? Everyone coming to a realization this is gonna be really bad in the future? Love to hear what Mr. Miami has to say, think this will be the nail in that coffin.
You think they want to address a recall while they are pumping the new 3D Tibia?
You know it’s bad when you ask higher ups about the recall, and instead of an intelligent answer you get belittled and questioned why you need to know. Hey JACKASS, we sell the knee. This must be bad….
The letter to surgeons is already out there. Just give them that and ask when they want to schedule their next revision 
the j&j attune guys have got to be relieved that it’s not just them.
the j&j attune guys have got to be relieved that it’s not just them.
Have there been any issues with the Vanguard and tibial loosening?
Call bezkak. He will tell you how to respond. If he calls back.
Heard there is a pretty big group of surgeons that got the letter and now questioning their own results…. How’s Zimmer gonna respond to that? Can’t hide forever!
Never used the nexgen nonaugmentable tibia, but seen many an augmentable option implanted. Any chance those become an issue in the future?
I don’t understand why we are just seeing these recalled now. They’ve been on the market forever
Michael Shane Gibson Mascotti call me directly anytime. When you have to sell that product that is non conforming so you can pay the lawyers and regulators. Poor business plan but you do you boo.