POLARCUP 75000666Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611996116809), received between Mar 9, 2020 and Sep 9, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARCUP TRIAL INSERT SLOTTED 28/51 WAS BROKEN UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170983 ↗
• MalfunctionJun 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARCUP TRIAL INSERT SLOTTED 28/51 BROKE DURING IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554350 ↗
• MalfunctionMar 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/51 BROKE UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987909 ↗
• MalfunctionDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE POLARCUP TRIAL INSERT SLOTTED 28/51 BROKE WHILE BEING USED OUTSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. HOWEVER, THERE WAS NO DELAY. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048235 ↗
• InjuryOct 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/51 BROKE IN TWO PIECES. THE TRIAL BROKE WHEN THE DR REDUCED THE HIP TO RANGE THE MOVEMENT AND CHECK STABILITY. THE DR DISLOCATED THE HIP AND PULLED OUT THE BROKEN TRIAL. IT WAS NOTICED EXCESSIVE WEAR AND TEAR ON THE POLY TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683501 ↗
• MalfunctionSep 10, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP TRIAL INSERT SLOTTED 28/51 CRACKED AFTER BEING USED. THIS HAPPENED AFTER USE IN PATIENT. 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 12457002 ↗
• InjuryMar 9, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE TRIALING INTRAOPERATIVELY. NO BACKUP WAS AVAILABLE BUT THE PROCEDURE COULD BE SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. THEREFORE, NO TIME WAS ADDED TO THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9808772 ↗