POLARSTEM 75002122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996096804), received between Feb 5, 2021 and Sep 11, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2024, PATIENT FELL AND SUFFERED FROM PERI PROSTHETIC FRACTURE OF FEMUR. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING REVISION SURGERY ON (B)(6) 2024, IN WHICH THE POLARSTEM STEM LATERAL 3 CEMENTED WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20190898 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 2ND STAGE REVISION ON (B)(6) 2020 DUE TO A LEFT THR INFECTION, PATIENT HAD ANOTHER INFECTION IN THE SAME HIP THEREFORE HAD A FIRST STAGE REVISION LEFT THR ON (B)(6) 2021. IT WAS INDICATED BY A DISEASES SPECIALIST A REVISION SURGERY TO REMOVE ALL PROSTHESIS AS THE ORGANISM CAUSING THE INFECTION IS SUSCEPTIBLE TO ANTIBIOTIC THAT THE PATIENT IS ALLERGIC. ALL PROSTHESIS WERE REMOVED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11284790 ↗