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POLARCUP 75000651Recalls & reported problems

Smith & Nephew, Inc. · POLARCUP TRIAL INSERT SLOTTED 22/43 · Class 1

All models of POLARCUP (61)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996116656), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 injury.

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

Device problems

  • Break1
  • Fracture1

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.

  • InjuryMar 24, 2022Break; Fracture; Break; Fracture

    IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARCUP TRIAL INSERT SLOTTED 22/43 BALL BROKE INTO PIECES WHEN INSERTING THE POLAR CUP. ALL THE PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13896887 ↗

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Sources and updates

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