POLARCUP 75023365Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611996112542), received between Dec 11, 2019 and Mar 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMar 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) POLARCUP TRIAL INSERT NAV 22/61 BROKE WHEN THE IMPLANT WAS BEING INSERTED. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. 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 21662040 ↗
• MalfunctionMar 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARCUP TRIAL INSERT NAV 22/61 BROKE UPON WHEN IMPLANTING THE POLAR CUP. ALL OF THE PLASTIC BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608428 ↗
• MalfunctionFeb 9, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR, (B)(4) POLARCUP TRIAL INSERT NAV 22/61 BROKE DURING TRIALS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND WHETHER THERE WAS ANY DELAY. HOWEVER, PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681547 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, A POLARCUP TRIAL INSERT NAV 22/61 BROKE DURING TRIALING. IT IS UNKNOWN HOW SURGERY WAS FINISHED AND IF THERE WAS A DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663099 ↗
• MalfunctionJun 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA, A POLARCUP REDUCER PART FOR IMPACTOR BROKE WHILE IMPACTING THE CUP. NO PIECE FELL INSIDE OF THE PATIENT'S INCISION. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14720259 ↗
• MalfunctionFeb 26, 2020Break; Break

  IT WAS REPORTED THAT THIS INSTRUMENT BROKE WHILE BEING USED, WHILE ADJUSTING THE IMPLANT IN POSITION. NO PIECES FELL INTO THE PATIENT'S WOUND AND THEREFORE, NO PIECES LEFT IN PATIENT. NO BACKUP WAS AVAILABLE NOR REQUIRED SINCE THE DEVICE BROKE AT THE END OF ITS USE. NO DELAY WAS RECORDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9757090 ↗
• MalfunctionDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING SURGERY, TRIAL SHATTERED INSIDE THE PATIENT WHEN BEING USED. NO DELAY WAS RECORDED AND NO BACKUP WAS AVAILABLE BUT SAME DEVICE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9450788 ↗