POLARCUP 75023714Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07611996114614), received between Mar 1, 2021 and Nov 26, 2024 — classified as 1 injury, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, TWO (2) POLARCUP REDUCER PART FOR IMPACTOR WERE BROKEN DURING IMPACTION OF THE CUP. NO PIECES IN THE PATIENT. 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 20788450 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT, ONE (1) POLARCUP REDUCER PART FOR IMPACTOR WAS BROKEN IN HALF UPON IMPACTION. IT IS UNKNOWN IF BROKEN PIECES FELL INTO 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 19662287 ↗
• MalfunctionApr 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE HEAD OF ONE (1) POLARCUP REDUCER PART FOR IMPACTOR WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663909 ↗
• 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 16584054 ↗
• MalfunctionNov 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARCUP REDUCER PART FOR IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709462 ↗
• MalfunctionSep 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A POLARCUP REDUCER PART FOR IMPACTOR BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467534 ↗
• MalfunctionAug 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET UP FOR A THR, THE TIP OF THE POLARCUP IMPACTOR HANDLE WAS NOTICED TO BE BENT FROM OVER USE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. AS THIS WAS NOTICED DURING SET UP, PATIENT WAS NOT YET INVOLVED. UPON VISUAL ANALYSIS, A POLARCUP REDUCER PART FOR IMPACTOR WAS RECEIVED AND WAS NOTICED TO BE FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283804 ↗
• MalfunctionAug 22, 2022Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TIP OF THE POLARCUP REDUCER PART FOR IMPACTOR IS BEAT UP AND CHIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272361 ↗
• MalfunctionJul 19, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE POLARCUP REDUCER PART FOR IMPACTOR BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058338 ↗
• MalfunctionMar 23, 2022Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT A POLARCUP REDUCER PART FOR IMPACTOR WAS FOUND TO BE CRACKED AND WITH GOUGES. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13858654 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED THAT, AFTER A THR THAT A POLARCUP REDUCER PART FOR IMPACTOR PLASTIC WAS NOTED TO BE CRACKED. PROCEDURE WAS FINISHED WITH THE SAME DEVICE, NO DELAY REPORTED. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202941 ↗
• MalfunctionApr 22, 2021Crack; Deformation Due to Compressive Stress; Crack; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE POLARCUP REDUCER PART FOR IMPACTOR IS DEFORMED, HAS CRACKS AND GOUGES. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11708074 ↗
• InjuryMar 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING IMPACTION. NO PARTS FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396838 ↗