POLARSTEM 75004678Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996109399), received between Jan 14, 2021 and Jun 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A POLARSTEM EXTRACTOR BLOCK BROKE INSIDE THE PATIENT UPON EXTRACTION. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR'S DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. 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 14672467 ↗
• MalfunctionMay 7, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING FIELD INSPECTION THE CS/CSL/GERADSCHAFT-PLUS EXTRACT.SCREW M6 AND THE POLARSTEM EXTRACTOR BLOCK WERE STRIPPED AND DID NOT ENGAGE PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793795 ↗
• InjuryJan 14, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE POLARSTEM EXTRACTOR BLOCK BROKE WHILE TRYING TO SLAP OUT AN IMPLANTED POLAR STEM. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO INJURY TO THE PATIENT WAS REPORTED. A SURGICAL DELAY OF 30 MIN OR LESS WAS REPORTED. THE NEWLY IMPLANTED STEM HAD TO BE EXTRACTED BECAUSE THE SURGEON WAS NOT ABLE TO REDUCE THE HIP AFTER IMPLANTING. AS A RESULT, THE STEM WAS DOWNSIZED AND SAT LOWER IN THE CANAL, CREATING ROOM FOR THE HIP TO BE REDUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11169250 ↗

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