FDA 522 Zimmer Metal-on-Metal Hip Explant Study

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FDA 522 Zimmer Metal-on-Metal Hip Explant Study | Zimmer Biomet | Zimmer Biomet

The Food and Drug Administration (FDA), pursuant to Section 522 of the Food, Drug and Cosmetic Act, 21 USC § 3601, has ordered medical device manufacturers, including Zimmer, Inc. (“Zimmer”), to conduct post market surveillance studies of their metal-on-metal hip implants.

Part of the post-market surveillance includes the study of explanted retrievals when made available after medically necessary surgical intervention. Below you will find copies of all the pertinent letters and forms for this activity.

FDA 522 Information

Procedures/Protocols

Zimmer Communications

Patient Consent/Decline