POLARCUP 75023346Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07611996112351), received between Mar 28, 2021 and Feb 29, 2024 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARCUP IMPACTOR PART FOR HANDLE BROKE DURING IMPACTION. NO PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807067 ↗
• MalfunctionNov 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP IMPACTOR PART FOR HANDLE BROKE WHILE IMPACTING CUP IN POSITION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209831 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE LIP ON THE POLARCUP IMPACTOR PART FOR HANDLE IS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18051021 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARCUP IMPACTOR PART FOR HANDLE BROKE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401185 ↗
• MalfunctionJun 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE POLARCUP IMPACTOR PART FOR HANDLE WAS CHIPPED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138319 ↗
• MalfunctionJun 15, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, A POLARCUP IMPACTOR PART FOR HANDLE WAS CHIPPED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137177 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, IN ONE (1) POLARCUP IMPACTOR PART FOR HANDLE TIP FRACTURED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071921 ↗
• 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 IMPACTOR HANDLE DEVICE 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 16584335 ↗
• InjuryMar 16, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY THE POLARCUP REDUCER PART FOR IMPACTOR BROKE. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. ALL PIECES RECOVERED FROM PATIENT'S WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777698 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT A POLARCUP IMPACTOR PART FOR HANDLE BROKE. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636077 ↗
• InjuryMar 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A POLARCUP IMPACTOR PART FOR HANDLE BROKE WHILE IMPACTING, NO PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY 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 13635638 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT, A POLARCUP TRIAL INSERT NAV 22/55 AND A POLARCUP IMPACTOR PART FOR HANDLE WERE NOTICED BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829581 ↗
• MalfunctionOct 15, 2021Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT, A POLARCUP IMPACTOR PART FOR HANDLE WAS FOUND CRACKED IN HALF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643410 ↗
• MalfunctionMar 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE POLARCUP IMPACTOR PART FOR HANDLE BROKE DURING PROCEDURE, WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580495 ↗