Recalled TKA implant yielded low midterm survivorship, high aseptic failure rates
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LAS VEGAS — Results presented here showed, prior to recall, a modern total knee arthroplasty implant had lower-than-expected midterm survivorship and higher-than-expected rates of aseptic failure.
“Post-recall, we expect these revision rates to rise dramatically and we’re currently working on updating our series now that it’s a year since the recall,” Simarjeet Puri said in his presentation at the American Academy of Orthopaedic Surgeons Annual Meeting. “We recommend that surgeons monitor patients with radiographs and advanced imaging and suggest that at the time of revision, surgeons are prepared for a difficult reconstruction with the use of augments, cones, sleeves and a higher constrained implant.”
Puri and colleagues retrospectively reviewed data for approximately 8,000 primary TKAs performed from 2010 to 2018 with an implant that was later recalled for a higher incidence of early wear, osteolysis and loosening.
“Importantly, last follow-up was in 2021, before the formal recall of this implant,” Puri said. “So, this study cohort represents patients that returned to our institution for follow-up with a specific complaint and not for surveillance.”
Researchers performed Kaplan-Meier analysis to determine survivorship and Cox regression analysis to examine the impact of patient variables and year of implantation on revision-free survival.
Overall, 369 TKAs required revision during the study period, with more than half of the revisions performed due to aseptic mechanical failure, according to Puri.
“We use the term aseptic mechanical failure as an umbrella term that defines a consistent constellation of findings that include polyethylene wear synovitis, osteolysis and component loosening of various severity,” Puri said.
Puri added that the now-recalled implant had a lower-than-expected survivorship, primarily driven by aseptic mechanical failures.
“Using Cox proportional hazard models, we also found young age and male sex were risk factors for both all-cause revision and revision specifically for aseptic mechanical failure,” Puri said. “Furthermore, in our study, implantation of the now-recalled insert from 2013 through 2018 conferred higher risk of revision for aseptic mechanical failure.”
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Chalmers B, et al. Paper 79. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 7-11, 2023; Las Vegas.
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