POLARSTEM 75100463Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07611996118544), received between Jan 3, 2020 and Feb 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 3, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE INNER PACKAGE OF ONE (1) POLARSTEM STEM STD TI/HA 0 NON-CEM WAS DAMAGED AND NO LONGER STERILE. 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 24245020 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A RIGHT THR ON (B)(6) 2013 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE NEAR THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022. DURING THIS PROCEDURE, THE FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, AND ACETABULAR LINER WERE REMOVED AND REPLACED WITH COMPETITOR'S DEVICES (STRYKER). 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 16282957 ↗
• InjuryFeb 1, 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) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT PRESENTED A PERI-PROSTHETIC FRACTURE THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL HEAD AND FEMORAL STEM WERE EXPLANTED. 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 16277836 ↗
• InjuryJan 19, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED MALALIGNMENT OF THE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM, 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: Failure of Implant

  MAUDE report 16209281 ↗
• InjuryDec 24, 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) 2021, THE POLYETHYLENE RING SEPARATED FROM THE CUP. THIS ADVERSE EVENT WAS SOLVED BY A EXPLANATION ON (B)(6) 2021. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13084285 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT FALL AND EXPERIENCED A FEMUR FRACTURE. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021 IN WHICH A POLARSTEM STEM STD TI/HA 0 NON-CEM AND A COCR 12/14 FEM HEAD 32 + 4 WERE EXPLANTED AND ACCORD TROCHANTERIC GRIP PLATE WAS IMPLANTED WITH CABLES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 12615263 ↗
• InjuryApr 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT AFTER A THR THE OXINIUM FEM HD 12/14 36 MM +0 BROKE NEAR THE DISTAL TIP. IT WAS NECESSARY REVISION SURGERY IN ORDER TO EXTRACT THE DISTAL TIP AND THIS WAS INCREDIBLY DIFFICULT. IT REQUIRED AN ETO AND CABLES. A REDAPT STEM X 240MM WAS IMPLANTED. THE PATIENT WAS NOT INJURED BEYOND THE DESCRIBED EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Implant Pain

  MAUDE report 11744276 ↗
• InjuryJan 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. PATIENT FELL OVER AND FRACTURED HER FEMUR. FRACTURE EXTENDED DOWN THE LESSER TROCHANTER. POLAR STEM AND HEAD WERE REMOVED AND 2 CABLES INSERTED TO REPAIR FRACTURE AND REDAPT STEM INSERTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9630679 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY OF THE STEM WAS PERFORMED DUE TO MEDIAL CALCAR FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9545904 ↗