POLARSTEM 75002112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996096682), received between Feb 19, 2025 and Sep 17, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Illegible 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Adverse 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) 2025, THE PATIENT EXPERIENCED A SPIRAL PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH POLARSTEM STEM STANDARD 1 CEMENTED WAS REPLACED AND A PLATE WAS USED TO ADDRESS THE PERIPROSTHETIC FRACTURE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 23073245 ↗
• MalfunctionMar 27, 2025Positioning Failure; Illegible Information; Positioning Failure; Illegible Information

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SURGEON WAS UNABLE TO SEE THE LASER ETCHED MARK ON ONE (1) POLARSTEM STEM STANDARD 1 CEMENTED. ALSO, WHEN SURGEON USED HEAD LAMP TO LOOK AT THE MARKS, THE REFLECTION MADE IMPOSSIBLE TO SEE ANY MARKING; THEREFORE, THIS CAUSED THE INCORRECT POSITION OF THE IMPLANT. A DOWNSIZE WAS REQUIRED TO ACHIEVE A SUITABLE OUTCOME FOR THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708700 ↗
• InjuryFeb 19, 2025Migration; Migration

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE POSTOPERATIVE X-RAY ON (B)(6) 2025 SHOWED THAT THE STEM HAD GONE OUT OF THE CANAL AT SOME POINT DURING SURGERY. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE POLARSTEM STEM STANDARD 1 CEMENTED WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21410911 ↗