Timely recognition of total elbow and radial head arthroplasty adverse events

an analysis of reports to the US Food and Drug Administration

Jeremy Somerson, Frederick A. Matsen

Research output: Contribution to journalArticle

Abstract

Background: Recent recalls of several commonly used elbow arthroplasty implants have prompted interest in the modes by which elbow implants fail and the timing of reports of these failures. Methods: We reviewed the adverse event reports to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from 2012 to 2015 regarding elbow arthroplasty to determine the event date and the type of each adverse event. Results: Among 179 total elbow adverse event reports, the most common modes of failure were implant dissociation (23%), loosening (22%), and infection (16%). The most common modes of failure among 58 radial head replacement reports were component dissociation (19%) and linkage screw failure (19%). The percentage distribution of adverse event types differed among different arthroplasty systems and from that reported in published reviews of elbow arthroplasty. Three implant recalls were implemented 2, 5, and 9 years after the first adverse event report in the MAUDE database. For 2 of the recalls, the first reports of the device failures were published 2 and 5 years after the first MAUDE reports. Conclusions: The MAUDE database is a publicly funded and publicly available means by which surgeons can identify adverse events for the prostheses they use before such information becomes available through journal publication or recall notification. In this study, MAUDE data revealed a higher relative frequency of mechanical dissociation of elbow implants than what has been represented in the literature. Early identification of these adverse events may help surgeons by informing their implant selection and surgical technique.

Original languageEnglish (US)
JournalJournal of Shoulder and Elbow Surgery
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

United States Food and Drug Administration
Elbow
Arthroplasty
Equipment and Supplies
Databases
Equipment Failure
Prostheses and Implants
Publications
Infection

Keywords

  • Case Series From Large Database Analysis
  • dissociation
  • Elbow arthroplasty
  • failure
  • Level IV
  • loosening
  • MAUDE database
  • recall
  • Treatment Study

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

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title = "Timely recognition of total elbow and radial head arthroplasty adverse events: an analysis of reports to the US Food and Drug Administration",
abstract = "Background: Recent recalls of several commonly used elbow arthroplasty implants have prompted interest in the modes by which elbow implants fail and the timing of reports of these failures. Methods: We reviewed the adverse event reports to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from 2012 to 2015 regarding elbow arthroplasty to determine the event date and the type of each adverse event. Results: Among 179 total elbow adverse event reports, the most common modes of failure were implant dissociation (23{\%}), loosening (22{\%}), and infection (16{\%}). The most common modes of failure among 58 radial head replacement reports were component dissociation (19{\%}) and linkage screw failure (19{\%}). The percentage distribution of adverse event types differed among different arthroplasty systems and from that reported in published reviews of elbow arthroplasty. Three implant recalls were implemented 2, 5, and 9 years after the first adverse event report in the MAUDE database. For 2 of the recalls, the first reports of the device failures were published 2 and 5 years after the first MAUDE reports. Conclusions: The MAUDE database is a publicly funded and publicly available means by which surgeons can identify adverse events for the prostheses they use before such information becomes available through journal publication or recall notification. In this study, MAUDE data revealed a higher relative frequency of mechanical dissociation of elbow implants than what has been represented in the literature. Early identification of these adverse events may help surgeons by informing their implant selection and surgical technique.",
keywords = "Case Series From Large Database Analysis, dissociation, Elbow arthroplasty, failure, Level IV, loosening, MAUDE database, recall, Treatment Study",
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AB - Background: Recent recalls of several commonly used elbow arthroplasty implants have prompted interest in the modes by which elbow implants fail and the timing of reports of these failures. Methods: We reviewed the adverse event reports to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from 2012 to 2015 regarding elbow arthroplasty to determine the event date and the type of each adverse event. Results: Among 179 total elbow adverse event reports, the most common modes of failure were implant dissociation (23%), loosening (22%), and infection (16%). The most common modes of failure among 58 radial head replacement reports were component dissociation (19%) and linkage screw failure (19%). The percentage distribution of adverse event types differed among different arthroplasty systems and from that reported in published reviews of elbow arthroplasty. Three implant recalls were implemented 2, 5, and 9 years after the first adverse event report in the MAUDE database. For 2 of the recalls, the first reports of the device failures were published 2 and 5 years after the first MAUDE reports. Conclusions: The MAUDE database is a publicly funded and publicly available means by which surgeons can identify adverse events for the prostheses they use before such information becomes available through journal publication or recall notification. In this study, MAUDE data revealed a higher relative frequency of mechanical dissociation of elbow implants than what has been represented in the literature. Early identification of these adverse events may help surgeons by informing their implant selection and surgical technique.

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