Sex and risk of hip implant failure: assessing total hip arthroplasty outcomes in the United States.

Importance: The role of sex in relationship to implant failure after total hip arthroplasty (THA) is important for patient management and device innovation.

Objective: To evaluate the association of sex with short-term risk of THA revision after adjusting for patient, implant, surgery, surgeon, and hospital confounders.

Design And Setting: A prospective cohort of patients enrolled in a total joint replacement registry from April 1, 2001, through December 31, 2010.

Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty.

Background: Randomized trials that sometimes serve as the basis for device approval are small, short term, and generalizable to an increasingly smaller percentage of patients. Some of the most common and challenging devices are those used in hip replacement. Artificial hips are implanted in thousands to alleviate pain caused by noninflammatory joint disease and to restore patient mobility.

Incidence and short-term outcomes of primary and revision hip replacement in the United States.

Background: The purpose of this study was to use 2003 nationwide United States data to determine the incidences of primary total hip replacement, partial hip replacement, and revision hip replacement and to assess the short-term patient outcomes and factors associated with the outcomes.

Methods: We screened more than eight million hospital discharge abstracts from the 2003 Healthcare Cost and Utilization Project Nationwide Inpatient Sample and approximately nine million discharge abstracts from five state inpatient databases. Patients who had undergone total, partial, or revision hip replacement were identified with use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes.

Medical device surveillance: gender differences in pulmonary artery rupture after pulmonary artery catheterization.

Background: Pulmonary artery (PA) rupture is a rare but often fatal complication of PA catheterization.

Methods: An analysis was performed of all the case reports of PA rupture after PA catheterization that were submitted to the Food and Drug Administration's Medical Device Reporting (MDR) system between the years 1991 and 2001. The MDR system is a national passive surveillance system that includes adverse event reports from such sources as manufacturers and healthcare professionals.

From controlled trials to clinical practice: monitoring transmyocardial revascularization use and outcomes.

Objectives: We sought to examine trends in the use and outcomes of transmyocardial revascularization (TMR) in community practice. We also identified important risk factors for TMR and compared outcomes of TMR combined with coronary artery bypass graft surgery (TMR + CABG) versus bypass alone in patients receiving incomplete revascularization.

Background: Although it is approved for use as a stand-alone procedure, there are limited data on the outcomes of (TMR + CABG).

Health effects associated with medical glove use.

Adverse reactions to medical gloves represent an important public health issue. Accordingly, there is increasing interest in understanding the information reported to the US Food and Drug Administration (FDA) describing health effects associated with the use of medical gloves. This article provides a retrospective analysis and summary of health effects associated with medical glove use reported to the FDA.