This study comes from the Karolinska Institute in Sweden and was reported in the Journal of Bone and Joint Surgery in July 1991. Researchers studied nine uncemented hip prostheses that had been revised (removed). In four of the nine hips, researchers found tissue discoloration and corrosion at the head-neck junction. […]
Search Results: 510k
Johnson & Johnson knew about at least some of the serious problems related to their DePuy ASR hip implant, known as metal-on-metal (MOM) implants, before they ever started alerting consumers and it appears they may have known about it even before they asked the FDA to approve the device through […]
Bloomberg has an interesting article today discussing medical device approval and where the fault lies for bad devices being approved for use. The Food & Drug Administration (FDA) “approves” medical devices and often (some say too often) grants review and approval under Section 510(k) of the Food, Drug & Cosmetic […]