POLARCUP 75000665Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611996116793), received between Aug 21, 2020 and Aug 21, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE IN HALF WHILE TRIAL REDUCING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. ALSO, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861601 ↗
• MalfunctionApr 1, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE IN HALF DURING TRIALING; ALSO, THE LOT NUMBER IS WORN AND CANNOT BE READ. ALL PIECES WERE ACCOUNTED FOR. 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 21749280 ↗
• MalfunctionApr 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, ONE (1) POLARCUP TRIAL INSERT SLOTTED 28/49 FRACTURED WHILE TRYING TO DISLOCATE HIP. SURGEON WAS DONE TRIALING SO NO BACKUP WAS NEEDED. NO PIECES FELL INTO 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 16748738 ↗
• InjuryOct 26, 2021Break; Break

  IT WAS REPORTED DURING A THR PROCEDURE, THAT A POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE. ALL PIECES WERE RETRIEVED. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, A DELAY OF 30 MINUTES OR LESS IS REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701852 ↗
• InjuryApr 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT, WHILE TRYING TO RELOCATE HIP, THE POLAR CUP TRIAL LINER 49 X 28 BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684521 ↗
• MalfunctionDec 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE. NO INFORMATION ABOUT SURGICAL DELAYS, S+N BACKUP DEVICES OR WHEN THIS INCIDENT HAPPENED WAS INITIALLY PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936649 ↗
• InjuryNov 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE INSIDE THE PATIENT. IT IS NOT KNOWN IF ALL PIECES WERE RECOVERED FROM THE WOUND AND HOW THIS PROCEDURE WAS COMPLETED. SURGERY WAS DELAYED FOR NO MORE THAN 30 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912882 ↗
• MalfunctionAug 21, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE POLARCUP TRIAL INSERT SLOTTED 28/49 BROKE. SURGERY HAD BEEN COMPLETED WITH THE SAME DEVICE SO IT WAS NOT DELAYED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437674 ↗