POLARSTEM 75100479Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07611996118704), received between Oct 9, 2018 and May 3, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2026Break

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, ONE (1) POLARSTEM STEM LAT.TI/HA 6 NON-CEM BROKE ON THE NECK. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25062854 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) POLARSTEM STEM LAT.TI/HA 6 NON-CEM, ONE (1) OXINIUM FEM HD 12/14 36 MM M/+4, ONE (1) R3 3 HOLE HA CTD ACET SHELL 56MM AND ONE (1) R3 0 DEG XLPE ACET LNR 36MM X MM56 WERE EXPLANTED AND A CEMENTED SPACER WAS INSERTED TO TREAT THE INFECTION. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22873149 ↗
• InjuryFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE POLARSTEM STEM LAT.TI/HA 6 NON-CEM BROKE WITHOUT TOO MUCH STRESS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE STEM WAS REPLACED WITH A REDAPT REVISION STEM. PATIENT´S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21393217 ↗
• MalfunctionApr 4, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT THE POLARSTEM STEM LAT.TI/HA 6 NON-CEM CAME WITH THE PACKAGING OPEN. IN ORDER TO USE IT, IT HAD TO BE STERILIZED AGAIN. THE SURGERY WAS COMPLETED, AFTER A DELAY GREATER THAN 30 MIN, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047302 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT PRESENTED A PERI-PROSTHETIC FRACTURE THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE FEMORAL HEAD AND STEM WERE EXPLANTED AND REPLACED WITH COMPETITOR DEVICES. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16205951 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED A PERI PROSTHETIC FRACTURE, THEREFORE, THE PATIENT NEEDED A REVISION STEM (WHICH WAS A STRYKER STEM) AND A HEAD/ POLY EXCHANGE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12701851 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE FEMUR WAS MILLED WITH A REAMER 6 AND WHEN THEY TRIED TO PLACE A STEM 6L WAS 1CM OUTSIDE THE FEMUR. THEN, SURGEON MILLED WITH A REAMER 7, BUT NOT COMPLETELY, AND TRIED TO PUT THE STEM 6 BACK BUT IT WAS STILL 5MM OUTSIDE. DR. OPENED A NEW 6L STEM AND IT WAS A PERFECT FIT. IN THIS PROCESS, A PERI-PROSTHETIC FRACTURE OCCURRED NEAR THE CALCAR FEMORAL AND IT WAS NECESSARY TO PUT A WIRE CERCLAGE. WITH THIS PROCESS THE SURGERY TOOK EXTRA 15 MINUTES, UNTIL THE USE OF THE NEW DEFINITIVE FEMORAL STEM.

  Patient problems: Hip Fracture

  MAUDE report 11009135 ↗
• InjuryNov 8, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A FALL POST OP AND NOW PRESENTS WITH PERI PROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8051509 ↗
• InjuryOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DELAYED HIP PROSTHESIS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7950203 ↗