Integra® Freedom Wrist Arthroplasty System 348292Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780066705), received between Nov 5, 2022 and Nov 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2022Nonstandard Device; Material Deformation; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT, DURING WRIST PROCEDURE, THE PERIPHERAL LIP OF THE CARPAL POLY. SIZE 1. +2 MM WAS WARPED UPON OPENING. ITEM WAS NOT IN GOOD WORKING CONDITION AS DESIGNED. TRIED TO SEAT IT OVER THE PERIPHERAL RIM OF THE CARPAL PLATE. UNFORTUNATELY, THE POLY IS SUPER FLIMSY AROUND THE RIM. IT DID NOT FIT APPROPRIATELY. WHEN IMPACTED THE POLY, IT BUCKLED UNDER AND COMPROMISED THE INTEGRITY AND ABILITY TO PROPERLY SEAT IT. THE PROCEDURE WAS RESUMED, WITHOUT A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740881 ↗