Descriptive analysis of postmarket surveillance data for hip implants.

Pharmacoepidemiology and Drug Safety
Josep PaneMiriam C J M Sturkenboom

Abstract

Recent safety issues involving medical devices have highlighted the need for better postmarket surveillance (PMS) evaluation. This article aims to describe and to assess the quality of the PMS data for a medical device and, finally, to provide recommendations to improve the data gathering process. A descriptive analysis of medical device reports (MDRs) on the use of MRA, a specific type of hip implant replacement submitted to the Food and Drug Administration Manufacturer and User Facility Device Experience database from 1 January 2008 to 31 December 2017. The number of reports was described as the number of MDRs per unique MDR number and stratified by different variables. The quality was assessed by the level of completeness of the collected PMS data. The total number of reports related to MRA was 2377, and the number of MDRs per year ranged between 84 in 2009 and 452 in 2017. Most of the reports were reported by manufacturer Depuy Johnson & Johnson and were reported by a physician. In 44.9% of the reports, the device problem was reported as "Unknown." When the device problem was known, in the majority of cases, it was related to an implant fracture. The quality of the collected data was assessed as low due to missing informati...Continue Reading

References

Jul 15, 2011·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Bruce Hugman
Jul 20, 2011·The Journal of Bone and Joint Surgery. British Volume·D J LangtonA V F Nargol
Jun 28, 2014·Hip International : the Journal of Clinical and Experimental Research on Hip Pathology and Therapy·Gulraj S MatharuDavid J Dunlop
Dec 9, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Josep PaneIrene Rebollo
Mar 25, 2017·Current Reviews in Musculoskeletal Medicine·Richard E HughesBrian R Hallstrom

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Citations

Sep 22, 2020·Expert Review of Medical Devices·Josep PaneMiriam C J M Sturkenboom
Mar 5, 2021·Medical Devices : Evidence and Research·Josep PaneMiriam C J M Sturkenboom

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