POLARSTEM 75100469Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611996118605), received between Feb 24, 2022 and Nov 6, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (3 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.

• InjuryNov 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT WANTED TO PUT ON HIS PANTS AND HEARD A CRACK IN HIS RIGHT HIP, WHICH WAS THE FRACTURE OF THE POLARSTEM STEM STD TI/HA 6 NON-CEM. SINCE THEN, HE HAS BEEN EXPERIENCING PAIN IN HIS RIGHT HIP. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6)2025, IN WHICH THE IMPLANTS WERE REVISED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Discomfort; Fall; Pain; Pelvic Pain

  MAUDE report 23485856 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR REVISION SURGERY HAD BEEN PERFORMED ON 16-SEP-2020 WITH LOOSENING OF THE SOCKET DIAGNOSIS, THE PATIENT EXPERIENCED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A SECOND REVISION SURGERY ON 24-SEP-2021. ACCORDING TO THE REPORT CONTENTS, THE FEMORAL STEM AND THE MODULAR HEAD WERE EXPLANTED AND REPLACED WITH A COMPETITORS DEVICE. 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 FIRST THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM FEMORAL PROSTHESIS AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16287672 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6)2014 WITH AN UNSPECIFIED DIAGNOSIS, THE PATIENT EXPERIENCED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6)2017. ACCORDING TO THE REPORT CONTENTS, THE FEMORAL STEM WAS EXPLANTED AND REPLACED WITH A COMPETITORS DEVICE. 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 FIRST THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM FEMORAL PROSTHESIS AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16286972 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS AVASCULAR NECROSIS AND CHRONIC TRAUMA, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD 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 16272151 ↗
• 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) 2020 TO ADDRESS AVASCULAR NECROSIS 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 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 16272068 ↗
• InjuryJan 23, 2023Fracture; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Fracture; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS AS PRIMARY DIAGNOSIS, THE PATIENT EXPERIENCED A LOOSENING AND A FRACTURE OF THE STEM COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM AND LINER WERE EXPLANTED AND REPLACED WITH SIMILAR DEVICES. 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: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16223992 ↗
• InjuryJan 20, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2011 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2011. DURING THIS PROCEDURE, THE FEMORAL STEM WAS EXPLANTED AND REPLACED WITH A COMPETITORS 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: Bone Fracture(s); Insufficient Information

  MAUDE report 16217985 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022 THE PATIENT EXPERIENCED DISLOCATION DUE TO THE COMPONENTS BEING PLACED IN A SUB-OPTIMAL POSITION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY TO EXPLANT THE COMPLETE SYSTEM ON (B)(6) 2022. THE PHYSICIAN REVISED A POLARSTEM STEM STD TI/HA 6 NON-CEM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13591087 ↗