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Adverse events associated with robotic-assistance in total hip arthroplasty: an analysis based on the FDA MAUDE database.
Graefe, S Bradley; Kirchner, Gregory J; Pahapill, Natalie K; Nam, Hannah H; Dunleavy, Mark L; Haines, Nikkole.
Afiliación
  • Graefe SB; Department of Orthopaedics and Rehabilitation, Penn State College of Medicine, Hershey, PA, USA.
  • Kirchner GJ; Department of Orthopaedics and Rehabilitation, Penn State College of Medicine, Hershey, PA, USA.
  • Pahapill NK; Department of Orthopaedics and Rehabilitation, Penn State College of Medicine, Hershey, PA, USA.
  • Nam HH; Department of Orthopaedics and Rehabilitation, Penn State College of Medicine, Hershey, PA, USA.
  • Dunleavy ML; Department of Orthopaedics and Rehabilitation, Penn State College of Medicine, Hershey, PA, USA.
  • Haines N; Department of Orthopaedics and Rehabilitation, Penn State College of Medicine, Hershey, PA, USA.
Hip Int ; 34(6): 688-694, 2024 Nov.
Article en En | MEDLINE | ID: mdl-39099264
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Bases de Datos Factuales / Artroplastia de Reemplazo de Cadera / Procedimientos Quirúrgicos Robotizados Límite: Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Hip Int Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Bases de Datos Factuales / Artroplastia de Reemplazo de Cadera / Procedimientos Quirúrgicos Robotizados Límite: Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Hip Int Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos