POLARSTEM 75100468Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07611996118599), received between May 31, 2021 and Jan 21, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER PRIMARY THR SURGERY HAD BEEN PERFORMED IN 2014, THE PATIENT WENT THROUGH A FIRST REVISION SURGERY IN 2017, DUE UNKNOWN REASON, IN WHICH THE HEAD AND THE CUP WERE EXPLANTED, LEAVING THE STEM. RECENTLY, THE PATIENT EXPERIENCED BREAKAGE OF THE CONE OF THE STEM, ON THE RIGHT SIDE. THE FRACTURE WAS DIAGNOSED ON (B)(6) 2024. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON UNKNOWN DATE, IN WHICH ONE (1) POLARSTEM STEM STD TI/HA 5 NON-CEM WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21197579 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD, LINER AND STEM WERE EXPLANTED. 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: Bone Fracture(s)

  MAUDE report 16272038 ↗
• InjuryJan 19, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A RIGHT THR WAS PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED LOOSENING OF THE STEM, AMONG WITH OTHER UNSPECIFIED COMPLICATIONS. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2015. DURING THIS PROCEDURE, THE STEM AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH A SMITH & NEPHEW BEARING COMBINATION. 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: Inadequate Osseointegration

  MAUDE report 16210565 ↗
• InjurySep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO PAIN AND DISLOCATION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 32MM -3 AND THE POLARSTEM STANDARD NON-CEMENTED WITH TI/HA 5, THE SURGEON SAID THE DEVICES WERE NOT DEFECTIVE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12446542 ↗
• MalfunctionMay 31, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING SURGERY, THE POLARSTEM STEM STD TI/HA 5 NON-CEM HAD POWDERY RESIDUE LEFT INSIDE PACKAGING. SURGEON WAS NOTIFIED BUT HAPPY TO USE IMPLANT. THE PROCEDURE WAS COMPLETED, WITH A DELAY (LESS THAN 30 MINUTES), USING THE SAME DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907558 ↗