POLARCUP 75000649Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07611996116632), received between Oct 14, 2020 and Nov 28, 2024 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2024Fracture; Fracture

  IT WAS REPORTED, THAT DURING IMPACTION OF THE POLARCUP SHELL IN A THR SURGERY. ONE (1) POLARCUP HANDLE ADAPT. 22MM TRIAL INSERT FRACTURED. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED WITHOUT DELAY. USING THE SAME DEVICE. AND NO INJURIES WERE REPORTED, AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805824 ↗
• MalfunctionApr 18, 2024Break; Crack; Fracture; Break; Crack; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP HANDLE ADAPT. 22MM TRIAL INSERT CRACKED AND BROKE DURING IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130509 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT ONE (1) POLARCUP HANDLE ADAPT. 22MM TRIAL INSERT IS BROKEN. 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 17487147 ↗
• InjuryApr 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE ADAPTER BROKE DURING IMPLANT IMPACTION. A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED IN ORDER TO COMPLETE THE PROCEDURE. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684523 ↗
• InjuryOct 14, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE POLARCUP HANDLE ADAPT. 22MM TRIAL INSERT BENT AND THEN BROKE INSIDE OF THE PATIENT. SURGERY WAS DELAYED FOR LESS THAN 30 MIN. AN S+N BACKUP DEVICE WAS AVAILABLE AND USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678861 ↗