POLARSTEM 75100478Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996118698), received between Sep 21, 2021 and Jan 27, 2023 — classified as 2 injuries, 1 malfunction.

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.

• InjuryJan 27, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT SURGERY PERFORMED ON (B)(6) 2013 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM, MODULAR HEAD WERE EXCHANGED WITH COMPETITOR 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: Bone Fracture(s); Failure of Implant

  MAUDE report 16258191 ↗
• InjuryJul 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY CONDUCTED ON (B)(6) 2022, A PATIENT SUFFERED A FRACTURE OF LEFT TROCHANTER. IT IS UNKNOWN WHETHER THIS OCCURRED WHILE POSITIONING THE POLARSTEM STEM LAT.TI/HA 5 NON-CEM STEM IMPLANT OR DURING FEMORAL PREPARATION PRIOR TO THE IMPLANT INSERTION. IT IS UNKNOWN IF THIS INCIDENT PROVOKED A SURGICAL DELAY. THIS ADVERSE EVENT WAS RESOLVED WITH CABLES DURING SURGERY. THE PATIENT'S CURRENT HEALTH STATUS IS RECOVERING AND RESOLVING.

  Patient problems: Hip Fracture

  MAUDE report 15090634 ↗
• MalfunctionSep 21, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, THE BOX OF A POLARSTEM STEM LAT.TI/HA 5 NON-CEM MUST HAVE TAKEN A BEATING AT SOME POINT IN TIME. THERE WAS AN INDENTATION IN THE LOWER PORTION OF THE BOX, AND THERE WAS A HOLE IN BOTH OF THE INNER WRAPPINGS, SO THE IMPLANT WAS NOT STERILE. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509737 ↗