S Bradley Graefe, Gregory J Kirchner, Natalie K Pahapill, Hannah H Nam, Mark L Dunleavy, Nikkole Haines
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引用次数: 0
Abstract
Background: The 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.
Methods: Medical 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.
Results: 521 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.
Conclusions: Identifying 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.
期刊介绍:
HIP International is the official journal of the European Hip Society. It is the only international, peer-reviewed, bi-monthly journal dedicated to diseases of the hip. HIP International considers contributions relating to hip surgery, traumatology of the hip, prosthetic surgery, biomechanics, and basic sciences relating to the hip. HIP International invites reviews from leading specialists with the aim of informing its readers of current evidence-based best practice.
The journal also publishes supplements containing proceedings of symposia, special meetings or articles of special educational merit.
HIP International is divided into six independent sections led by editors of the highest scientific merit. These sections are:
• Biomaterials
• Biomechanics
• Conservative Hip Surgery
• Paediatrics
• Primary and Revision Hip Arthroplasty
• Traumatology