POLARCUP 75023359Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996112481), received between Mar 7, 2021 and Mar 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP TRIAL INSERT NAV 22/49 BROKE WHILE INSIDE THE WOUND. ALL PIECES WERE ACCOUNTED FOR AND REMOVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITHOUT THE NEED FOR ANY ADDITIONAL INSTRUMENTS. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909033 ↗
• MalfunctionOct 22, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP TRIAL INSERT NAV 22/49 BROKE OFF OUTSIDE OF THE WOUND AFTER BEING USED. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681104 ↗
• MalfunctionMar 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE POLARCUP TRIAL INSERT NAV 22/49 BROKE APART WHEN BEING DISASSEMBLED ON THE BACK TABLE AND NEEDS REPLACING. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429706 ↗