POLARSTEM 75004646Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996097535), received between Apr 22, 2024 and Sep 3, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.

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

• MalfunctionSep 3, 2024Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  IT WAS REPORTED THAT DURING A THA SURGERY, A POLARSTEM DETACHABLE RASP 5 BECAME STUCK TO A POLARSTEM COLLAR REAMER GUIDE AND COULD NOT BE REMOVED. IT WAS MENTIONED THAT THE POLARSTEM DETACHABLE RASP 5 HAD ALSO BEEN STICKING TO THE HANDLES AND NECK TRIALS. THE PROCEDURE RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY UPSIZING TO A SIZE 6 RASP WITHOUT PERFORMING THE CALCAR REAMING. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126149 ↗
• InjuryApr 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, AFTER REAMING WITH THE POLARSTEM DETACHABLE RASP 5 AND IMPLANTING THE SIZE 5 STEM, THE PATIENT EXPERIENCED A PROXIMAL FEMUR CRACK, REQUIRING THE PLACEMENT OF A CABLE AROUND THE FRACTURE SITE. SUBSEQUENTLY, AFTER REAMING WITH THE POLARSTEM DETACHABLE RASP 6 AND IMPLANTING THE SIZE 6 STEM, THE PATIENT EXPERIENCED A DISTAL FEMUR FRACTURE, REQUIRING THE USE OF A CABLE TO SECURE THE FRACTURE. BOTH RASPS WERE FOUND TO BE DULL, AND THEY WERE COMPACTING INSTEAD OF CUTTING AS INTENDED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICES. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 19153939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116