POLARCUP 75023364Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07611996112535), received between Mar 25, 2020 and Jan 9, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, TWO TABS OF ONE (1) POLARCUP TRIAL INSERT NAV 22/59 BROKE OFF DURING IMPACTION OF THE POLAR CUP. THE TWO PIECES FELL INSIDE PATIENT'S WOUND AND WERE RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITHOUT THE USAGE OF THE REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030466 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARCUP TRIAL INSERT NAV 22/59 BROKE UPON USE. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761749 ↗
• MalfunctionMay 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, A PART OF THE PLASTIC OF ONE (1) POLARCUP TRIAL INSERT NAV 22/59 BROKE OFF WHEN THE ACETABULAR COMPONENT WAS BEING IMPLANTED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. THE BROKEN PIECES WERE RECOVERED BY HAND AND SUCTION. NO PARTS WERE LEFT IN THE PATIENT, AND EVERYTHING WAS ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336755 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A POLARCUP TRIAL INSERT NAV 22/59 WAS BROKEN, ANY PIECE FELL INSIDE THE WOUND, THE TRIAL INSERT BROKE INTO THE TRIAL CUP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY; HOWEVER, IT REMAINS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858125 ↗
• MalfunctionJul 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP TRIAL INSERT NAV 22/59 FRACTURED. 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 17424313 ↗
• MalfunctionSep 9, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARCUP TRIAL INSERT NAV 22/59 BROKE UPON IMPACTION. 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 15396411 ↗
• InjuryJul 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE POLARCUP TRIAL INSERT NAV 22/59 WAS BROKEN. DEVICE OUTSIDE THE PATIENT. 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 15136221 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PLASTIC ON THE SIDE OF A POLARCUP TRIAL INSERT NAV 22/59 BROKE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. AS THIS HAPPEN AFTER PROCEDURE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644827 ↗
• MalfunctionMay 31, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSPECTION, THE POLARCUP TRIAL INSERT NAV 22/59 WAS FOUND TO BE DAMAGED WITH GOUGES IN THE PLASTIC. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907556 ↗
• InjuryOct 14, 2020Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE POLARCUP TRIAL INSERT NAV 22/59 BROKE INTO MANY PIECES WHILE BEING USED. NO INJURIES OR SURGICAL DELAYS REPORTED. PROCEDURE WAS FINISHED CHANGING THE SURGICAL TECHNIQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10679060 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE POLARCUP TRIAL INSERT SHATTERED DURING USE. NO DELAY WAS REPORTED AND NO BACKUP DEVICE WAS AVAILABLE SO IT IS UNKNOWN HOW THE PROCEDURE CONCLUDED. NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9878531 ↗