POLARSTEM 75100475Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07611996118667), received between Aug 24, 2018 and Jan 27, 2023 — classified as 10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM AND MODULAR HEAD WERE EXCHANGED WITH SMITH & NEPHEW 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); Failure of Implant

  MAUDE report 16258245 ↗
• InjuryJan 19, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A RIGHT THR WAS PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED LOOSENING OF THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE STEM WAS REMOVED AND REPLACED WITH AN UNKNOWN IMPLANT. THIS INFORMATION WAS PROVIDED BY THE (B)(6), 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.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16210707 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR WAS PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED PERI-PROSTHETIC FRACTURE NEAR THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2015. DURING THIS PROCEDURE, THE STEM AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH A COMPETITOR'S (STRYKER) BEARING COMBINATION. 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: Hip Fracture

  MAUDE report 16210662 ↗
• 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 WAS PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED PERI-PROSTHETIC FRACTURE NEAR THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2015. DURING THIS PROCEDURE, THE STEM AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH A COMPETITOR'S DEVICE BEARING COMBINATION. 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: Hip Fracture

  MAUDE report 16210608 ↗
• InjuryOct 6, 2021Adverse 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) 2021, THE PATIENT EXPERIENCED FRACTURE OF GREATER TUBEROSITY. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021 IN WHICH AN OXINIUM FEM HD 12/14 32MM -3 AND A POLARSTEM STEM LAT.TI/ HA 2 NON-CEM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 12583535 ↗
• MalfunctionDec 15, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A THR PROCEDURE, A PROBLEM HAS BEEN DETECTED REGARDING PACKAGING WITH LOSS OF STERILITY. THE LAST PLASTIC OF THIS STEM WAS OPENED IN THE DISTAL PART, SO THE SURGEON DECIDED NOT TO USE THE DEVICE. SURGERY WAS DELAYED FOR NO MORE THAN 30 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11009068 ↗
• InjuryJan 7, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC FRACTURE. STEM WAS LOOSED AND THEREFORE WAS EXCHANGED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9560590 ↗
• InjuryOct 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A PATIENT EXPERIENCED HYPOXIA WHILE SLEEPING IN POST-ANESTHESIA CARE UNIT. THE EVENT REQUIRED TO EXTEND HOSPITALIZATION TO GET IT RESOLVED ON (B)(6) 2019. THIS IS UNRELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 9167871 ↗
• InjuryJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED RIGHT HIP PAIN. IT IS UNKNOWN THE REASON FOR THE PAIN OR IF A REVISION SURGERY HAS BEEN PERFORMED.

  Patient problems: Injury

  MAUDE report 8244866 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER REMOVING 2 BROACH, SURGEON NOTED A LONGITUDINAL FRACTURE APPROXIMATELY 3CM DOWN THE LENGTH OF FEMUR AND THEN TURNED POSTERIORLY. EVENT MARKED AS SERIOUS. INTRAOPERATIVE PERIPROSTHETIC FRACTURE OF RIGHT FEMUR. NO BROACH DETAILS ARE KNOWN AT THIS POINT. PLEASE NOTE THAT ON (B)(6) 2018 AEMB CONSIDERED THIS EVENT TO BE RELATED TO THE SURGICAL TECHNIQUE OF FEMORAL STEM AND THUS TO THE POLARSTEM DEVICE, WHICH IS NOT THE STUDY DEVICE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7866712 ↗
• InjuryAug 24, 2018Fracture; Fracture

  A REVISION SURGERY WAS REPORTED TO CORRECT A STEM SUBSIDENCE AND A PERIPROTHETIC FRACTURE. THE SURGEON THINKS THAT THE CAUSE OF THIS EVENT IS DUE TO THE STEM BEING UNDERSIZE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7814816 ↗