ArticleHip international : the journal of clinical and experimental research on hip pathology and therapy2024
Adverse events associated with robotic-assistance in total hip arthroplasty: an analysis based on the FDA MAUDE database.
Article in Hip international : the journal of clinical and experimental research on hip pathology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Failure modes of robotic-assisted arthroplasty platforms in Australia: a descriptive analysis of TGA adverse event reports.Journal of robotic surgery · 2026Article
- Application of snake model imaging selection and analysis to the ultrasound diagnosis of white matter damage in preterm infants.BMC medical imaging · 2025Article
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Authors and funding
6 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database for reporting adverse events associated with medical devices, including emerging technologies, such as robotic-assisted total hip arthroplasty (THA). Aim of this study was to evaluate the variation of adverse events associated with robotics in THA.
methodsMedical device reports (MDRs) within the MAUDE database were identified between 2017 and 2021. For MDR identification the product class "orthopaedic stereotaxic equipment" and terms associated with THA were used. Individual adverse events were identified and organised by type and consequences, such as patient injury, surgical delay, or conversion to the manual technique.
results521 MDRs constituting 546 discrete events were found. The most common reported complication was intraoperative hardware failure (304/546, 55.7%), among which the most common failure was a broken impaction handle/platform (110, 20.1%). Inaccurate cup placement was the second most common reported complication (63, 11.5%). Abandoning the robot occurred in 13.0% (71/521) of reports. A surgical delay was noted in 28% (146/521) of reports, with an average delay of 17.9 (range 1-60) minutes.
conclusionsIdentifying complications that may occur with robotics in THA is an important first step in preventing adverse events and surgical delays. Database analysis provide an overview of the range of complications.
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