POLARCUP 75000664Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996116786), received between May 20, 2021 and Apr 16, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, A POLARCUP TRIAL INSERT SLOTTED 28/47 SNAPPED INTO TWO BITS WHILE REDUCING THE HIP JOINT. ALL PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901671 ↗
• InjuryMay 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARCUP TRIAL INSERT SLOTTED 28/47 WAS BROKEN. THE PROCEDURE WAS COMPLETED, WITH A DELAY (LESS THAN 30 MINUTES) , USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855852 ↗