POLARSTEM 75102205Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556535493), received between Jun 22, 2020 and Jul 10, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K143739, K211548); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785459 ↗
• MalfunctionJun 22, 2026Fracture

  IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT SURGERY, THE RELEASE LEVER OF ONE (1) POLARSTEM COLLAR REAMER GUIDE SNAPPED OFF AFTER BECOMING UNABLE TO MOVE. NO PIECES REQUIRED REMOVAL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573018 ↗
• MalfunctionApr 22, 2026Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARSTEM COLLAR REAMER GUIDE WAS CUT UP AND DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952910 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE HOOK OF THE POLARSTEM COLLAR REAMER GUIDE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821162 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR USING ONE (1) POLARSTEM COLLAR REAMER GUIDE, AN ISSUE OCCURRED DURING THE CALCAR REAMING STEP ON THE FEMORAL SIDE; WHILE REAMING OVER THE COLLAR REAMER GUIDE, THE METAL GUIDE BROKE. UPON REMOVAL, IT WAS OBSERVED THAT THE RETENTION HOOK PIECE HAD DETACHED. THE BROKEN FRAGMENT WAS RETRIEVED FROM THE SURGICAL SITE WITH FORCEPS, AND A PART-TO-PART MATCH WAS PERFORMED TO CONFIRM THAT NO FRAGMENTS REMAINED IN THE WOUND. THE PROCEDURE CONTINUED WITHOUT FURTHER EVENTS AND WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. NO SURGICAL DELAY WAS ENCOUNTERED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22604011 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT ONE (1) POLARSTEM COLLAR REAMER GUIDE WAS BROKEN. THE EXACT TIMING OF THE EVENT RELATIVE TO THE THR SURGERY IS UNKNOWN. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552827 ↗
• MalfunctionMay 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, WHEN THE CALCAR REAMER WAS PLACED OVER THE POLARSTEM COLLAR REAMER GUIDE AND THE REAMER WAS TURNED ON, IT CAUGHT THE CALCAR GUIDE AND SNAP IT IN TWO. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19410611 ↗
• MalfunctionAug 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT A POLARSTEM COLLAR REAMER GUIDE FAILED THE INSPECTION. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED. THE RESULTS OF INVESTIGATION CONFIRMED THAT THIS PRODUCT WAS FRACTURED, WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370529 ↗
• InjuryAug 4, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE AND INSIDE OF THE PATIENT THE SPRING MECHANISM OF THE POLARSTEM COLLAR REAMER GUIDE BROKE WHILE IN USE. SURGICAL DELAY WAS GREATER THAN 30 MIN AND IT IS NOT KNOWN HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10364018 ↗
• MalfunctionJun 26, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE FAILED DURING PROCEDURE. IT WAS CONFIRMED, IN AN ADDITIONAL INFORMATION, THAT THE DEVICE BROKE, HOWEVER NO PIECES FELL INSIDE THE WOUND. ALL FRAGMENTS WERE DISPOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200775 ↗
• MalfunctionJun 22, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT WHEN CLEANING AND PUTTING THE POLARSTEM COLLAR REAMER GUIDE SET TOGETHER, THE SPRING CAME OUT OF THE REAMER GUIDE. NO PROCEDURE-RELATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181828 ↗
• MalfunctionJun 22, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE ITEM CLIP AND SPRING BROKE APART. NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10181758 ↗
• InjuryJun 22, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE FAILED UPON INSPECTION IN OFFICE. NO PATIENT INVOLVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10180070 ↗
• InjuryJun 22, 2020Break; Break

  PRIMARY - DR USED THE INSTRUMENT WITH THE HOOK BEING BROKE OFF BUT REQUESTED IT BE REPLACED. NO DELAY & THE PATIENT WAS NOT AFFECTED. REP IS UNCERTAIN HOW IT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10180067 ↗
• MalfunctionJun 22, 2020Connection Problem; Connection Problem

  (B)(6) REF# (B)(4): THIS IS A LOANER KIT COMPLAINT AND IT WAS FOUND DURING INSPECTION AT OUR WAREHOUSE. THE MOVEMENT PART OF THE REAMER GUIDE IS RAISING OUT OF THE MAIN BODY, SO IT MAKES THE DEVICE DIFFICULT TO ATTACH TO THE CALCAR REAMER. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10180059 ↗
• MalfunctionJun 22, 2020Break; Break

  PIECE BROKEN OFF, DO NOT HAVE THAT PIECE TO RETURN. THE PIECE WAS RETRIEVED BUT WAS LOST IN THE DECONTAMINATION PROCESS IN SPD. [NIL, (B)(6) 2017] CONFIRMATION THAT THE SPRING WAS REMOVED FROM THE WOUND AND FOLLOWING STATEMENT RECEIVED: "THE SURGEON REAMED THE CALCAR THEN COULD NOT DISENGAGE THE NECK. IT BROKE WHILE TRYING TO DISLODGE IT FROM THE BROACH. THE CALCAR REAMING PROCESS IN THE POLAR STEM IS CUMBERSOME."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10180009 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739, K211548. One submission often covers many models, so check the product and lot details in each record.

• Z-2827-2020 · Jul 22, 2020 · Open, Classified
  POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the