POLARSTEM 75100481Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996118728), received between Mar 4, 2021 and Dec 26, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THR SURGERY, THE STERILITY OF ONE (1) POLARSTEM STEM LAT.TI/HA 8 NON-CEM WAS IN QUESTION SO IT WAS NOT IMPLANTED AFTER BEING OPENED. THERE WERE HOLES IDENTIFIED IN THE PACKAGING. 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 18393572 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT THR ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE NEAR THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH COMPETITOR'S DEVICES (STRYKER). THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Hip Fracture

  MAUDE report 16282970 ↗
• MalfunctionMar 4, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING THE PREPARATION OF THE MATERIAL FOR SURGERY, WHEN THE STEM WAS REMOVED FROM THE PACKAGING, IT WAS FOUND THAT THE INNERMOST PACKAGING LEVEL DID NOT HAVE A VACUUM OR WAS SEALED. THE PRODUCT WAS NOT USED DUE TO THE RISK OF NOT BEING STERILE. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409074 ↗