POLARSTEM 75023711Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 07611996114393), received between Dec 10, 2018 and Apr 23, 2026 — classified as 28 injuries, 146 malfunctions.

The most frequently reported specific device problem is “Fracture” (105 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Fracture

  IT WAS REPORTED THAT, DURING A HEMI HIP SURGERY, AFTER IMPACTING THE FEMORAL HEAD, BLACK PLASTIC CHIPS WERE COMING OFF THE POLARSTEM MODULAR HEAD FOR 21000662. THIS WAS NOTICED UNTIL THE CASE WAS OVER, SO THE SURGERY WAS COMPLETED WITH THE SAME REPORTED DEVICE, WITHOUT ANY DELAY. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973676 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT, DURING A THR, ONE (1) POLARSTEM MODULAR HEAD FOR (B)(6) CHIPPED DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. 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 24663243 ↗
• MalfunctionMar 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE IMPACTING THE HEAD ON TO THE STEM, ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, A BACK-UP DEVICE WAS NOT NEEDED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542265 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARSTEM MODULAR HEAD FOR 21000662 CHIPPED OFF WHILE IN USE. ALL PIECES RECOVERED. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY, OR IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364566 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, TWO (2) POLARSTEM MODULAR HEAD FOR 21000662 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 24103332 ↗
• MalfunctionDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA SURGERY, THE POLARSTEM MODULAR HEAD FOR (B)(4) TIP BROKE AND THE FRAGMENTS WERE ALL ACCOUNTED FOR AND DISPOSED. NO PIECE FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23938158 ↗
• MalfunctionDec 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) POLARSTEM MODULAR HEAD FOR (B)(4)CRACKED WHEN REDUCING A HIP. NO PARTS OF THE BROKEN IMPACTOR FELL INTO THE WOUND OF THE PATIENT. ALL PARTS WERE RETRIEVED FROM THE FLOOR OF THE SURGICAL SUITE AND ACCOUNTED FOR. THE PIECES THAT FRAGMENTED WERE DISPOSED OF PROPERLY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888606 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE WHILE REDUCING THE HIP AT THE END OF THE CASE. THE BROKEN PIECE FELL ON THE FLOOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23784506 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY THE BLACK CAP OF ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE WHILE IMPACTING THE HEAD. THE PIECE THAT CAME OFF WENT INTO THE WOUND, THERE WAS ONLY ONE PIECE THAT BROKE OFF AND THE DOCTOR REMOVED IT BY PICKING IT UP WITH HIS HANDS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700901 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC OF ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 CHIPPED OFF DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY SURGICAL DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694407 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THA SURGERY THE PLASTIC OF ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459961 ↗
• MalfunctionOct 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE POLARSTEM MODULAR HEAD FOR 21000662 BROKE INTO TWO PIECES WHENEVER HAMMERING THE OXINIUM HEAD ON TO THE POLARSTEM. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343879 ↗
• MalfunctionSep 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE MODULAR HEAD FOR 21000662 32-36MM BROKE WHEN IMPACTING THE FEMORAL HEAD ONTO THE POLAR STEM. THE HEAD WAS SEATED ONTO THE STEM SO NO ADDITIONAL EQUIPMENT WAS NEEDED. ALL PIECES OF THE BROKEN HEAD IMPACTOR WERE COLLECTED TO ENSURE NOTHING WAS LEFT BEHIND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23163950 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY THE EDGE OF ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE OFF DURING IMPACTION OF FEMORAL HEAD. A FRAGMENT FELL OFF THE FIELD AND WAS RETRIEVED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062782 ↗
• MalfunctionSep 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A BILATERAL QUADRILATERAL ARTHROPLASTY PROCEDURE, AT THE END OF THE SURGERY AFTER IMPACTING THE OXINIUM HEAD, ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 FRACTURED. THE PROCEDURE WAS COMPLETED, WITHOUT ANY SURGICAL DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946047 ↗
• MalfunctionAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, AFTER PUTTING ONE (POLARSTEM MODULAR HEAD FOR 21000662) ON STEM, THE MODULAR HEAD CRACKED, AND PIECE CAME OFF. THE FRAGMENT WAS RETRIEVED MANUALLY, AND NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900829 ↗
• MalfunctionMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARSTEM MODULAR HEAD FOR 21000662 BROKE OFF AFTER IMPACTION. NOTHING FELL INTO THE WOUND. ALL PIECES WERE RETRIEVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102110 ↗
• MalfunctionMay 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE WHILE ATTEMPTING TO REDUCE THE FEMORAL HEAD IMPLANT INTO THE LINER SOCKET. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085067 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE TIP OF ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 BROKE. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024141 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) POLAR STEM MODULAR HEAD FOR 21000662 BROKE WHILE INSERTING THE HEAD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990808 ↗
• MalfunctionMay 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 HAD A LARGE PIECE BROKEN OFF. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970053 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE BLACK TIP OF ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 CHIPPED OFF AND BROKE WHILE BEING IMPACTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932401 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY WHILE IMPACTION TWO (2) POLARSTEM MODULAR HEAD FOR 21000662 THE TIPS BROKE, ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895544 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, TWO (2) POLARSTEM MODULAR HEADS FOR 21000662 BROKE DURING IMPACT. IT IS UNKNOWN HOW THE PROCEDURE FINISHED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543313 ↗
• MalfunctionMar 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) POLARSTEM MODULAR HEAD FOR 21000662 WAS BROKEN. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. IT IS UNKNOWN HOW THE PROCEDURE FINISHED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540539 ↗