POLARSTEM 75102207Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556535516), received between Aug 15, 2019 and Oct 8, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

1 other recall cover devices cleared under the same FDA submission (K143739); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARSTEM COLLAR CALCAR REAMER SMALL HAD METAL FILINGS/DEBRIS. THE AFFECTED AREA WAS HEAVILY IRRIGATED AND SUCTIONED TO REMOVE ALL DEBRIS. ALL THE BROKEN PIECES WERE REMOVED AND ACCOUNTED. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. FOLLOWING THE CASE THE REAMER WAS INSPECTED AND WAS FOUND THERE WAS WEAR IN THE CALCAR REAMER AND ON THE TRUNION INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397827 ↗
• InjuryNov 13, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A THR SURGERY, AFTER BROACHING THE FEMORAL CANAL, IT WAS ASKED TO OPEN THE POLARSTEM CALCAR REAMERS. THE NURSE OPENED THE TRAY AND THE SURGEON ATTEMPTED TO REAM ACCORDING TO TECHNIQUE; HOWEVER, THE POLARSTEM CALCAR REAMER 40MM WAS NOT LOWERING ONTO THE POLARSTEM CALCAR REAMER GUIDE AND WAS SWINGING IN THE AIR. THE SURGEON ASKED IF THERE WAS A PROBLEM WITH THE COLLAR OF THE NECK MODULE OR IF IT WAS THE POLARSTEM REAMERS AND NOT FROM OTHER COMPANIES. IT WAS GOT THE SECOND LOAN TRAY AVAILABLE AND WHEN THE SURGEON REPEATED THE PROCESS, THIS TIME THE POLARSTEM CALCAR REAMER 40MM WAS EXTREMELY AGGRESSIVE, CAUSING HIM TO LOSE CONTROL OF THE DRILL AND CAUSE A SMALL FRACTURE IN THE PROXIMAL FEMUR. THIS PROMPTED HIM TO ASK IF THERE WERE ANY CABLES ON THE SHELF THAT HE COULD USE TO SECURE AND FIX IT AND, FORTUNATELY, SYNTHES CABLES WERE AVAILABLE. THE SURGEON USED A CABLE, AND THE CASE WAS RESUMED BY IMPLANTING THE CEMENTED POLARSTEM STEM AND FINALIZING THE CASE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. A SMALL FRACTURE AROUND THE PROXIMAL FEMUR NEAR THE OSTEOTOMY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM. IT WAS RESOLVED

  Patient problems: Bone Fracture(s)

  MAUDE report 18120803 ↗
• InjuryApr 19, 2022Dull, Blunt; Adverse Event Without Identified Device or Use Problem; Dull, Blunt; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THR SURGERY THE POLARSTEM COLLAR CALCAR REAMER SMALL WAS DULL AND FRACTURED PATIENT´S CALCAR. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 14140477 ↗
• InjuryAug 15, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING SURGERY, WHILE REAMING THE CALCAR BY USING THE CALCAR REAMER, THE FEMORAL BONE WAS BROKEN.

  Patient problems: Bone Fracture(s)

  MAUDE report 8899760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739. 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