POLARCUP 75023344Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07611996112337), received between Mar 17, 2021 and Dec 3, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A POLARCUP REDUCER PART FOR IMPACTOR BROKE WHILE BEING HAMMERED DURING REDUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833249 ↗
• MalfunctionMar 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE HEAD PUSHER TIP OF ONE (1) POLARCUP REDUCER PART FOR IMPACTOR BROKE IN HALF WHILE IMPACTING THE FEMORAL HEAD. ONE PIECE FELL ON THE FLOOR AND THE OTHER FELL INTO THE INCISION AND WAS RETRIEVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956618 ↗
• MalfunctionMar 21, 2023Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF THE POLARCUP REDUCER PART FOR IMPACTOR BROKE WHILE USING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, CHANGING SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584053 ↗
• MalfunctionJun 25, 2022Break; Flaked; Break; Flaked

  IT WAS REPORTED THAT, A PORTION OF THE POLARCUP REDUCER PART FOR IMPACTOR WAS CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14819227 ↗
• InjuryMay 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP REDUCER PART FOR IMPACTOR BROKE INSIDE PATIENT DURING IMPACTION. ALL PIECES WHERE RETRIEVED BY HAND. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519789 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION OF A TOTAL HIP REPLACEMENT THE POLARCUP REDUCER PART FOR IMPACTOR WAS MISSING FORM TRAY DUE TO BEING BROKEN AND DISCARDED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11500023 ↗