POLARSTEM 75100472Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996118636), received between Dec 26, 2018 and Jan 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 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) 2011 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE-STEM AND UNEXPLAINED PAIN THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2015. 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); Pain

  MAUDE report 16204457 ↗
• InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATIONS OF LEFT TOTAL HIP ARTHROPLASTY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8195761 ↗