POLARCUP 75023358Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996112474), received between Dec 30, 2021 and May 12, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARCUP TRIAL INSERT NAV 22/47 BROKE INTO THREE (3) PIECES INSIDE THE PATIENT, PIECES WERE REMOVED WITH KOCHER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924673 ↗
• MalfunctionJun 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE POLARCUP TRIAL INSERT NAV 22/47 IS FRACTURED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14781724 ↗
• MalfunctionDec 30, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP TRIAL INSERT NAV 22/47 WAS NOTICED TO BE CRACKED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119131 ↗