POLARSTEM 75102238Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556535417), received between Jan 20, 2020 and May 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMay 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARSTEM KNOCK PLATE LARGE POPPED OFF THE BROACH HANDLE. THE PROCEDURE WAS FINISHED WITHOUT DELAYS AND WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT WAS HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817229 ↗
• MalfunctionOct 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE AND OUTSIDE THE PATIENT THE POLARSTEM KNOCK PLATE LARGE BROKE WHILE BEING MALLETED DURING SURGERY. NO INJURIES OR SURGICAL DELAYS REPORTED. IT IS NOT KNOWN HOW THIS PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10646377 ↗
• MalfunctionJan 20, 2020Break; Break

  SURGEON STATES THAT WHEN THE MALLET HITS THE POLAR BROACH HANDLE STRIKE PLATES, METAL FLAKES GO FLYING. NO DELAY TO PROCEDURE, NO INJURY TO PATIENT. S&N BACKUP WAS AVAILABLE. NO CLOSURE LETTER NEEDED. DEVICE WILL BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9608470 ↗

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