POLARCUP 75023360Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611996112498), received between Mar 10, 2021 and Jan 24, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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.

• MalfunctionJan 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE POLARCUP TRIAL INSERT NAV 22/51 BROKE AFTER IT WAS DONE BEING USED IN THE OPERATIVE SITE. ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231533 ↗
• MalfunctionFeb 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A PIECE OF THE POLARCUP TRIAL INSERT NAV 22/51 BROKE WHILE IMPACTING THE CUP. THE DEVICE WAS LOCATED INSIDE THE PATIENT AT THE MOMENT OF THE ISSUE BUT ALL THE PIECES WERE RETRIEVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406348 ↗
• InjuryFeb 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP TRIAL INSERT NAV 22/51 BROKE WHILE IMPACTING. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THEN 30 MIN, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476407 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR THE PLASTIC RIM OF A POLARCUP TRIAL INSERT NAV 22/51 BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741252 ↗
• MalfunctionApr 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TRIAL CRACKED DURING USE, WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610532 ↗
• MalfunctionMar 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF THE TRIAL INSET CRACKED AND FELL OF. THE EVENT OCCURRED DURING SET UP OR INSPECTION. A SN BACKUP DEVICE WAS AVAILABLE IN ORDER TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468388 ↗
• MalfunctionMar 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TRIAL WAS FOUND BROKEN IN SET DURING SET UP OR INSPECTION. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11450010 ↗