POLARCUP 75023362Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07611996112511), received between Dec 31, 2019 and Dec 19, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE POLARCUP TRIAL INSERT NAV 22/55 BROKE DURING IMPACTION. 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 20977490 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, A PIECE OF THE (1) POLARCUP TRIAL INSERT NAV 22/55 BROKE OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449281 ↗
• MalfunctionDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) POLARCUP TRIAL INSERT NAV 22/55 CRACKED AND THEN BROKE OFF 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 16048234 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A POLARCUP TRIAL INSERT NAV 22/55 BROKE DURING IMPACTION OF THE CUP, HOWEVER ALL THE PIECES WERE RETRIEVED. THE DEVICE WAS LOCATED OUTSIDE THE PATIENT AT THE MOMENT OF THE ISSUE. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE AND WITHOUT DELAY. NO OTHER COMPLICATIOS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879756 ↗
• MalfunctionNov 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THR, A PART OF THE BACK LIP OF ONE (1) POLARCUP TRIAL INSERT SLOTTED 22/55 BROKE WHILE PLACING THE TRIALS INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. 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 15788810 ↗
• InjuryJun 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT A POLARCUP TRIAL INSERT NAV 22/55 BROKE INTO PIECES. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14720713 ↗
• MalfunctionJun 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A POLARCUP TRIAL INSERT NAV 22/55 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 14672545 ↗
• MalfunctionNov 17, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, A POLARCUP TRIAL INSERT NAV 22/55 AND A POLARCUP IMPACTOR PART FOR HANDLE WERE NOTICED BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831118 ↗
• MalfunctionDec 31, 2019Break; Break

  IT WAS REPORTED THAT LINER TRIAL BROKE IN MULTIPLE PIECES DURING IMPLANT FINAL IMPACTION. UNKNOWN DELAY OCCURRENCE. NO BACKUP WAS AVAILABLE.

  Patient problems: No Information

  MAUDE report 9537004 ↗