POLARSTEM 75100480Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611996118711), received between Jan 19, 2023 and Nov 24, 2023 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THA OF THE RIGHT HIP ON (B)(6) 2017, THE PATIENT EXPERIENCED AN HETEROTOPIC BONE FORMATION ON THEIR RIGHT HIP. TO RESOLVE THIS ISSUE, THE OSSIFICATION WAS EXCISED ON (B)(6) 2021. DURING THIS SURGERY, ONCE THE BONE WAS REMOVED AROUND THE PROSTHESIS, IT WAS NOTED THAT THE ACETABULAR COMPONENT WAS STABLE. THE FEMORAL COMPONENT WAS STABLE. THERE WAS NO WEAR OF THE POLYETHYLENE. DESPITE THE BEST EFFORTS TO CREATE NO DAMAGE IN THE FEMORAL HEAD, THERE WERE A COUPLE SMALL SCRATCHES FROM THE OSTEOTOME IN A NON-WEIGHT BEARING AREA NEAR THE TRUNNION ON THE FEMORAL BALL. THIS WAS FOUND TO BE IN A SATISFACTORY LOCATION AND THERE WAS NO CHANCE OF WEAR. FURTHERMORE, ON (B)(6) 2022, THE PATIENT EXPERIENCED THEIR HIP GIVING OUT, PAIN, AND SUBSEQUENTLY FELL TO THE GROUND. THE X-RAYS SHOWED A FRACTURE AT THE TRUNNION OF THE FEMORAL STEM. THIS CONDITION WAS TREATED BY PERFORMING A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2022, DURING WHICH THE FEMORAL STEM AND THE FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW HIGH-OFFSET FEMORAL STEM, AN OXINIUM FEMORAL HEAD AND FOUR SETS OF ACCORD CABLES AND CLAMPS. THIS REVISION SURGERY WAS SIGNIFICANTLY MORE COMPL

  Patient problems: Arthralgia; Extraskeletal ossification; Failure of Implant; Fall; Loss of Range of Motion

  MAUDE report 18204431 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2012 WITH A HEAD IMPLANT FRACTURE, LYSIS OF THE STEM AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS DIAGNOSIS, THE PATIENT EXPERIENCED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2019. ACCORDING TO THE REPORT CONTENTS, THE FEMORAL STEM WAS EXPLANTED AND REPLACED WITH SMITH AND 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 FIRST THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM FEMORAL PROSTHESIS AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16286954 ↗
• 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 RIGHT SURGERY PERFORMED ON (B)(6) 2020 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE FEMORAL STEM AND MODULAR HEAD WERE EXCHANGED 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); Failure of Implant

  MAUDE report 16257983 ↗
• 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 INDEX SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUFFERED FROM A PERI-PROSTHETIC FRACTURE OF THE STEM AND AN INFECTION, WHICH MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE ALL THE COMPONENTS WERE EXPLANTED AND REPLACED. 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); Unspecified Infection

  MAUDE report 16205958 ↗