POLARSTEM 75004650Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07611996097573), received between Feb 26, 2021 and Feb 5, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE END TURNING PART (ROD) OF ONE [1] POLARSTEM STEM INSERTER BROKE OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313548 ↗
• MalfunctionOct 10, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN THE THE STEM WAS BEING IMPLANTED, THE POSITIONER WAS HAMMERED AND WHEN THE STEM WAS GOING TO BE RELEASED, THE NUT OF THE POLARSTEM STEM INSERTER GOT STUCK AND WOULD NOT RELEASE, IT WAS NECESSARY TO MAKE SEVERAL MANEUVERS UNTIL IT WAS RELEASED BUT THE STEM NUT FELL OFF. ALSO, THE POLARCUP HEAD/LINER INSERTER, WHEN ASSEMBLED, HAD A KIND OF MISALIGNMENT THAT DID NOT SEEM NORMAL. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICES. THE PATIENT'S HEALTH WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418039 ↗
• MalfunctionSep 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE POLARSTEM STEM INSERTER BROKE WHILE BEING STRUCK WITH THE MALLET. AT THIS TIME IT IS UNKNOWN IF ANY PIECES FELL INTO THE PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302067 ↗
• MalfunctionMar 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE WASHER / NUT PIECE OF THE POLARSTEM STEM INSERTER BROKE DURING IMPLANTATION OF THE POLARSTEM. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968996 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY THE THREADED ROD BROKE WHILE IT WAS CONNECTED TO THE IMPLANT. THE SURGEON COULD NOT GET IT OFF SO HE HAD TO SAW OFF THE PLASTIC NECK GUIDE AND USE A METAL CUTTING BURR TO REMOVE THE INSERTER. IT IS UNKNOWN IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118976 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, TWO (2) POLARSTEM STEM INSERTER BROKE WHILE TRYING TO INSERT THE POLARSTEM. NO PIECES FELL INSIDE THE WOUND. 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 18029110 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE POLARSTEM FIN STABILIZER FOR 21000300 DEVICE SNAPPED DURING USE. 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 16448716 ↗
• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A POLARSTEM STEM INSERTER BROKE INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192161 ↗
• MalfunctionApr 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA, THE POLARSTEM STEM INSERTER BROKE. IT IS UNKNOWN IF ANY FRAGMENT FELL INSIDE OF THE PATIENT. SURGERY WAS COMPLETED FREEHANDEDLY WITH A DELAY OF LESS THAN 30 MIN. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975337 ↗
• MalfunctionApr 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THA, THE POLARSTEM STEM INSERTER BROKE. IT IS UNKNOWN IF ANY FRAGMENT FELL INSIDE OF THE PATIENT. SURGERY WAS COMPLETED FREEHANDEDLY WITH A DELAY OF LESS THAN 30 MIN. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975130 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, TWO (2) POLARSTEM STEM INSERTER ARE BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER, THERE WAS A DELAY OF LESS THAN 30 MIN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935325 ↗
• MalfunctionMar 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT , THE POLARSTEM STEM INSERTER WAS BROKEN. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716140 ↗
• MalfunctionJan 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CIRCULAR TOP OF A POLARSTEM STEM INSERTER HAS DETACHED FROM THE ROD THAT LOCKS TO THE STEM. SURGERY WAS CONTINUED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13403965 ↗
• MalfunctionSep 17, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12489441 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, A POLARSTEM STEM INSERTER BROKE. THE INCIDENT OCCURRED WITH THE INSTRUMENT OUTSIDE THE PATIENT. A SMITH AND NEPHEW BACKUP DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE, NO DELAY REPORTED. PATIENT NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305469 ↗
• MalfunctionMay 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE HEADED END OF A POLARSTEM STEM INSERTER HAS SHEARED OFF. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872739 ↗
• MalfunctionApr 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING POST SURGERY INSPECTION FOR A THR PROCEDURE, THE POLARSTEM STEM INSERTER DID NOT LONGER ENGAGE TO SCREW DOWN. THE MATERIAL OF THE PRODUCT IS TWISTED / BENT. HERE WAS NO A DELAY, A S&N BACK UP WAS AVAILABLE IF NEEDED. THE PATIENT OUTCOME IS FINE. INVESTIGATION DETERMINED THAT THE DEVICE IS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692484 ↗
• InjuryFeb 26, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT, DURING A PRIMARY SURGERY OF SN DEVICES, THE INSERTER CAN INTRAOPERATIVELY ONLY BE REMOVED FROM THE POLARSTEM IMPLANT WITH HIGH FORCE AND THE ASSOCIATED ROTATION OF THE STEM. THE STEM WAS QUICKLY REMOVED AND MOST OF THE CEMENT WAS RECOVERED WITH THE SHARP SPOON. A SIZE 6 STEM CAN NO LONGER BE ACCOMMODATED, SO A SIZE 5 WAS USED. HERE TOO, WAS A ROTATIONAL MALALIGNMENT, SO THAT THE PROSTHESIS AND CEMENT WERE REMOVED AS SOON AS POSSIBLE. FINALLY, AN EVEN SMALLER STEM WAS IMPLANTED MANUALLY. A SURGICAL DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Physical Asymmetry

  MAUDE report 11388983 ↗