RESTORIS 186040-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486009892), received between Apr 15, 2024 and Apr 18, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Corroded” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2024Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE PATIENT'S RIGHT HIP REVISION. IT WAS REPORTED BY AN ATTORNEY THAT PLAINTIFF UNDERWENT A REVISION OF A HIP DUE TO ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 19130536 ↗
• InjuryApr 15, 2024Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PLAINTIFF UNDERWENT A REVISION OF A HIP DUE TO ADVERSE LOCAL TISSUE REACTION. THIS PI IS FOR THE PATIENT'S LEFT HIP REVISION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 19104326 ↗