POLARSTEM 75100471Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611996118629), received between Apr 11, 2021 and Nov 22, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INDEX THR PROCEDURE PERFORMED DURING AN UNSPECIFIED DATE, THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2024 TO REVISE THE FEMORAL STEM DUE TO POSTOP. INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 20758446 ↗
• MalfunctionJul 28, 2021Tear, Rip or Hole in Device Packaging; Scratched Material; Tear, Rip or Hole in Device Packaging; Scratched Material

  IT WAS REPORTED THAT, DURING A THA, A POLARSTEM STEM STANDARD TI/HA 8 NON-CEM WAS NOT PACKAGED SECURELY, WHICH CAUSED THE STEM'S COATING TO SCRATCH OFF WITH THE PLASTIC. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239439 ↗
• InjuryMay 11, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE OPENING THE ENVELOPE OF A POLARSTEM STEM STD TI/HA 8 NON-CEM WAS PUNCTURED AND THERE WAS NO VACUUM. AS THIS WAS NOTICED DURING SET UP, THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808829 ↗
• MalfunctionApr 11, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE, THE BOX WAS OPENED AND THE OUTER PACKAGING WAS FINE, BUT WHEN THE CIRCULATOR WENT TO HAND THE IMPLANT TO THE SURGICAL TECH, THE IMPLANT WAS POKING OUT OF THE PLASTIC. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646730 ↗