POLARCUP 75017089Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07611996103151), received between Oct 29, 2020 and Jul 9, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THR SURGERY, THE NUB ON THE TIP OF ONE (1) POLARCUP HEAD/LINER INSERTER WAS MISSING. 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 19702236 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE METAL HANDLE OF THE POLARCUP HEAD/LINER INSERTER BROKE WHERE IT CONNECTS WITH THE BLUE PIECE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183467 ↗
• MalfunctionSep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE POLARCUP HEAD/LINER INSERTER BLUE HEAD IS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426445 ↗
• MalfunctionMar 30, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC NIPPLE OF A POLARCUP HEAD/LINER INSERTER BROKE OFF. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945864 ↗
• MalfunctionFeb 16, 2022Crack; Crack

  IT WAS REPORTED THAT, THE PLASTIC PART OF THE POLARCUP HEAD/LINER INSERTER CRACKED OFF. AS THIS WAS NOTICE DURING SET UP OR INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540344 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT THE POLARCUP HEAD/LINER INSERTER BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389636 ↗
• MalfunctionJan 12, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PLASTIC PIECE OF THE BALL HEAD PRESS OF A POLARCUP HEAD/LINER INSERTER HAS COME APART AND IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237285 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT A POLARCUP HEAD/LINER INSERTER IS BROKEN. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919901 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY THE BLUE PLASTIC OF POLARCUP HEAD/LINER INSERTER SNAPPED OFF. SURGERY WAS FINISHED WITH OR3O CLAMP, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752169 ↗
• MalfunctionAug 19, 2021Crack; Crack

  IT WAS REPORTED DURING A THR THE BLUE PLASTIC PIECE OF A POLARCUP HEAD/LINER INSERTER IS CRACKED. PROCEDURE WAS FINISHED WITH THE SAME DEVICE, NO DELAY REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345475 ↗
• MalfunctionAug 16, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE POLARCUP HEAD/LINER INSERTER WAS CRACKED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328932 ↗
• MalfunctionJul 7, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, THE POLARCUP HEAD/LINER INSERTER WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131297 ↗
• InjuryJun 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR THE PROCEDURE THEPOLARCUP HEAD/LINER INSERTER DID NOT FUNCTION PROPERLY. THE DEVICE WAS DISCOVERED TO BE FRACTURED. NO HARM TO PATIENT OR STAFF. NO SUPPLEMENTAL PATIENT INFORMATION IS CURRENTLY AVAILABLE. NO SUBSTANTIAL PROCEDURAL DELAY BECAUSE A FUNCTIONING, SMITH & NEPHEW BACK UP WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE. 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 11971339 ↗
• MalfunctionApr 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PLASTIC OF THE POLARCUP HEAD/LINER INSERTER WAS FOUND BROKE OFF. NO INFORMATION ABOUT SURGICAL DELAYS OR BACKUP DEVICES WAS INITIALLY PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646687 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR THE BLUE NIPPLE PLASTIC PART OF THE POLARCUP HEAD/LINER INSERTER BROKE OFF. INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612238 ↗
• MalfunctionNov 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE POLARCUP HEAD/LINER INSERTER BROKE DURING A THR PROCEDURE, IT IS NOT KNOWN IF THE DEVICE BROKE INSIDE THE PATIENT. A S+N BACKUP DEVICE WAS AVAILABLE AND USED TO COMPLETE THE SURGERY. NO SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912913 ↗
• MalfunctionOct 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT POLARCUP HEAD/LINER INSERTER FRACTURED. THIS WAS NOTICED UPON INSPECTION OF INSTRUMENT RECEIPT. NO INFORMATION ABOUT SURGICAL DELAYS, S+N BACKUP DEVICES OR WHEN THIS INCIDENT HAPPENED WAS INITIALLY PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10754572 ↗