POLARSTEM 75023710Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07611996114386), received between Nov 10, 2020 and Sep 23, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A THR SURGERY ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 CAME OFF FROM ONE (1) POLARSTEM BALL HEAD IMPACTOR AND GOT WEDGED BEHIND THE ACETABULUM. THE POLARSTEM MODULAR HEAD FOR 21000662 WAS NOT RETAINING WELL ENOUGH ON THE HANDLE AND WAS RETRIEVED WITH DIFFICULTY USING LONG FORCEPS. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT SURGICAL DELAY GREATER THAN 30 MINUTES USING A COMPETITOR DEVICE (STRYKER HEAD PUSHER). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123947 ↗
• MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, DURING HANDLING ACTIVITIES, THE POLARSTEM BALL HEAD IMPACTOR CAME OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167496 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARSTEM BALL HEAD IMPACTOR PLASTIC BROKE UP DURING IMPACTION OF THE FEMORAL HEAD. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393561 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE POLARSTEM BALL HEAD IMPACTOR TIP WAS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241722 ↗
• MalfunctionFeb 16, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE POLARSTEM BALL HEAD IMPACTOR BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED, OR FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543317 ↗
• MalfunctionJan 27, 2022Crack; Crack

  IT WAS REPORTED THAT THE POLARSTEM BALL HEAD IMPACTOR IS CRACKED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13372183 ↗
• MalfunctionAug 3, 2021Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT A POLARSTEM MODULAR HEAD FOR 21000662 CRACKED. IT IS UNKNOWN WHEN THIS WAS PROBLEM WAS NOTICED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267473 ↗
• MalfunctionMay 21, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TIP OF A POLARSTEM BALL HEAD IMPACTOR IS JAMMED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862440 ↗
• MalfunctionMay 17, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER PROCEDURE, WAS NOTICED THAT THE BLACK BUMPER TIP THAT CONNECTS TO THE POLARSTEM BALL HEAD IMPACTOR ON WAS FOUND TOO STIFF TO REMOVE ON TWO DEVICES AFTER USE FOR CLEANING (B)(4). THERE WAS NO PATIENT INVOLVED SINCE THE EVENT WAS NOTICED AFTER PROCEDURE. TWO POLARSTEM MODULAR HEAD FOR 21000662 (B)(4) WERE RECEIVED, IT IS UNKNOWN WHAT TYPE OF FAILURE DO THESE DEVICES HAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838434 ↗
• MalfunctionMay 17, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER PROCEDURE, WAS NOTICED THAT THE BLACK BUMPER TIP THAT CONNECTS TO THE POLARSTEM BALL HEAD IMPACTOR ON WAS FOUND TOO STIFF TO REMOVE ON TWO DEVICES AFTER USE FOR CLEANING (B)(4). THERE WAS NO PATIENT INVOLVED SINCE THE EVENT WAS NOTICED AFTER PROCEDURE. TWO POLARSTEM MODULAR HEAD FOR 21000662 (B)(4) WERE RECEIVED, IT IS UNKNOWN WHAT TYPE OF FAILURE DO THESE DEVICES HAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838407 ↗
• InjuryMar 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE IMPACTOR (CASE-(B)(4)) BROKE DURING USE, DUE TO WEAR AND TEAR. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO INJURY TO THE PATIENT WAS REPORTED. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488230 ↗
• InjuryNov 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE POLARSTEM BALL HEAD IMPACTOR BROKE WHILE IMPACTION INSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10815706 ↗