POLARCUP 75023361Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996112504), received between Jan 22, 2021 and Feb 27, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, A PIECE OF A POLARCUP TRIAL INSERT NAV 22/53 BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448531 ↗
• MalfunctionJun 17, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, A POLARCUP TRIAL INSERT NAV 22/53 BROKE WHILE IMPACTING. SURGERY WAS FINISHED WITH A SN BACK-UP DEVICE AND NO DELAY WAS REPORTED. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739009 ↗
• InjuryJan 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT HE PLASTIC ON TRIAL CHIPPED OF DURING USE, WHILE INSIDE THE PATIENT. CASE FINISHED WITH NO ISSUES. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11218199 ↗