Investigate The Adverse Events Related to Oxinium Implants

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Date

2024

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Newcastle Univarsity

Abstract

The use of medical devices is increasing day-by-day, an important category of medical devices are the implants, such as orthopedics implants. Hip implants have been studied extensively and various materials are researched to improve the working of these implants. The wear properties are being tested for Oxinium implant which has shown to be potentially less harmful. However, many adverse events have been reported. In order to analyze the current harmful effects of Oxinium hip implant the FDA database for adverse events known as MAUDE is used in this study. The analysis of the reported adverse events provides a real-world analysis of the commercially available implants. The study of recent events can provide in-depth knowledge of potential design or procedural flaws which can be rectified to ensure patient’s safety globally. This study analyzed the recent 4 years data of MAUDE, from which 470 adverse events were obtained. Statistical analysis using excel and python was done to identify unique product codes, plot relations between different variables, and identify device problems and adverse events. Design related adverse events were found to be more common than material related events.

Description

Disease or damage of natural joints can significantly affect the quality of a person’s life by causing severe pain and restricting movements. One of the common treatments for diseased joints involves surgical replacement of joints with implants predominantly hip and knee implants. The frequency of hip surgeries is increasing due to large number of elder populations. However, these surgeries are benefiting the younger generation as well. Compared to the knee implants hip surgeries have better survival rate and enhancing the quality of implant used in the treatment can be a successful approach for extending their durability and service life, avoiding additional surgeries (Katz, Arant and Loeser, 2021). In the past, people who had orthopedic problems were sometimes called "Cripples"; and with a limited understanding of musculoskeletal anatomy and function it is understandable that why this might have been so. This gap in knowledge frequently led to catastrophic results of cases such as trauma, degenerative joint disease, and infections with high risk for severe disabilities or death. However, with research and knowledge three main areas of hip surgery have evolved: surgical approaches and anatomical considerations, trauma management, and joint replacement. The entire specialty/field for the research and development of new surgical techniques, biomaterials ensuring hip implant long-term survival came into existence primarily because surgical intervention was necessitated (Bota et al., 2021).

Keywords

Oxinium hip implant

Citation

Investigate The Adverse Events Related to Oxinium Implants

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