Orthopedic implant retrieval--imperatives and possibilities.
Premature orthopedic implant failure occurs for a variety of reasons. In such scenarios implant retrieval is an issue that has a potential for further investigation leading to redesign of components and to improve implant longevity. While strict standards must be adhered to in order to gain FDA approval to use an implant, capturing, and recording the contributing factors leading to explantation and that of retrieved implant is neither strictly adhered to nor enforced. This article presents data illustrating implant standards both pre-market approval as well as in the retrieval scenarios. This paper provides a compilation of specific specifications on implant retrieval handling and storage, compelling imperatives and possibilities at national or global scale. The need for a user-definable, searchable interface is proposed in this paper to facilitate such an important task.
Yeakley
Brian
B
Department of Biomedical Industrial and Human Factors Engineering, Wright State University, Dayton, OH 45435, USA.
Goswami
Tarun
T
D020878:Device Removal / Q000592:standards*; D038622:Internationality; D019221:Mandatory Reporting; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D019736:Prostheses and Implants / Q000592:standards*; D011475:Prosthesis Failure