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POLARCUP 75017083Recalls & reported problems

Smith & Nephew, Inc. · POLARCUP EXTRACTOR PE-INSERT · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996098013), received between Nov 22, 2021 and Nov 22, 2021 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 22, 2021Break; Break

    IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT THE PLASTIC PEG OF A POLARCUP EXTRACTOR PE-INSERT HAD BROKEN OFF IN THE STERILIZER. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT 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 12857788 ↗

Other EXTRACTOR devices

All EXTRACTOR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.