POLARCUP 75023363Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611996112528), received between Oct 26, 2020 and Dec 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED, THAT, DURING A THR SURGERY. A POLARCUP TRIAL INSERT NAV 22/57 BROKE, DURING REDUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED, AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833260 ↗
• MalfunctionAug 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE POLARCUP TRIAL INSERT 57/22 BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. SURGERY WAS *PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REP%ORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017091 ↗
• MalfunctionFeb 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE POLARCUP TRIAL INSERT NAV 22/57 WAS BROKEN. 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 18727229 ↗
• MalfunctionDec 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A PIECE OF AN UNKNOWN TRIAL INSERT BROKE OFF DURING REDUCTION. THE BROKEN PIECE WAS RETRIEVED. NO DELAY WAS REPORTED, BUT IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378227 ↗
• MalfunctionMar 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, ONE (1) OF THE FINS ON POLARCUP TRIAL INSERT NAV 22/57, BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 16547109 ↗
• MalfunctionJun 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A POLARCUP TRIAL INSERT NAV 22/57 IS BROKEN. IT IS UNKNOWN AT WHAT STAGE OF THE SURGERY THE INCIDENT OCCURRED. HOWEVER, IT IS KNOWN THAT A SN BACK-UP DEVICE WAS AVAILABLE AND THAT THERE WAS NO DELAY IN SURGERY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED. 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 14672546 ↗
• MalfunctionOct 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE POLARCUP TRIAL INSERT NAV 22/57 BROKE IN SEVERAL PIECES. IT IS NOT KNOWN IF IT WAS INSIDE OF THE PATIENT. PROCEDURE WAS FINISHED WITH AN S+N BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10737961 ↗