POLARSTEM 75100467Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07611996118582), received between Mar 10, 2018 and Jul 27, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, during the first week of recovery following a BHR to THR conversion performed on (b)(6) 2018, the patient experienced persistent pain in the anterior groin. It is particularly painful when lifting the right leg, when he goes from sitting to standing, and getting into or out of cars. The pain is described as burning sharp sensation, and the patient reported weakness and limited movement. The patient received a fluoroscopy guided injection in the iliopsoas bursa on (b)(6) 2025, but he states that it really did not help at all. A recent MRI on (b)(6) 2026 revealed mild capsulitis, capsular fluid prolapsing into the iliopsoas bursa, and mild thickened synovium. The adverse event had not been resolved. A revision surgery has been scheduled for ON (b)(6) 2026.

  Patient problems: Bursitis; Implant site sclerosis; Pain; Prolapse

  MAUDE report 50029306 ↗
• InjuryNov 7, 2024Migration; Migration

  IT WAS REPORTED THAT, AFTER A THR SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEMORAL STEM SUBSIDENCE AND PAIN. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) POLARSTEM STEM STD TI/HA 4 NON-CEM, ONE (1) OXINIUM FEM HD 12/14 32 MM +0, AND ONE (1) R3 0 DEG XLPE ACET LNR 32 MM X 50 MM WERE REVISED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 20630543 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2023, POST-OP X-RAY AND CT SCANS WERE PERFORMED ON (B)(6) 2023, IT WAS DETERMINED THAT THE PATIENT'S IMPLANT WAS MAL POSITIONED AS A RESULT OF A PREVIOUS NONUNION OF A FEMORAL FRACTURE. THIS ADVERSE EVENT WAS TREATED VIA REVISION SURGERY ON (B)(6) 2023, IN WHICH A POLAR-STEM STD TI/HA 4 NON-CEM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17803106 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT ADMITTED WITH QUERY PAIN IN HIP AND X-RAY INDICATED SUBSIDENCE OF FEMORAL STEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 AND, UPON OPENING THE JOINT, SURGEON FOUND SIGNS OF PUS, WHICH INDICATED SEPSIS. THE IMPLANTS WERE SUBSEQUENTLY REMOVED AND CEMENT SPACER USED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Sepsis

  MAUDE report 17455758 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2012 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE MODULAR HEAD AND 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 16271980 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2014 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD AND STEM WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF 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. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16259427 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS CONGENITAL DISLOCATION, DYSPLASIA OF THE HIP AND OSTEOARTHRITIS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD AND 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 16259334 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE MODULAR HEAD AND 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 16259273 ↗
• InjuryJan 19, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT THR WAS PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED LOOSENING OF 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: Inadequate Osseointegration

  MAUDE report 16210627 ↗
• InjuryJan 19, 2023Fracture; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS TRAUMA SYMPTOMS, THE PATIENT SUSTAINED LOOSENING ¿ STEM AND IMPLANT FRACTURE - STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM WAS 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; Inadequate Osseointegration

  MAUDE report 16209298 ↗
• 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 SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE-STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2015. DURING THIS PROCEDURE, THE MODULAR HEAD AND 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 16204222 ↗
• InjuryJan 18, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2017TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT THE LOOSENING AND MALALIGNMENT OF THE FEMORAL COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE FEMORAL STEM AND HEAD WERE EXPLANTED AND REPLACED WITH A COMPETITORS FEMORAL SYSTEM. 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: Inadequate Osseointegration

  MAUDE report 16200365 ↗
• InjuryJan 18, 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) 2017 WITH AVASCULAR NECROSIS AND OSTEOARTHRITIS AS PRIMARY DIAGNOSES, THE PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE ASSOCIATED TO THE FEMORAL COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE FEMORAL STEM AND HEAD WERE EXPLANTED AND REPLACED WITH COMPETITORS 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: Hip Fracture

  MAUDE report 16200213 ↗
• InjuryJan 18, 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) 2017 WITH CONGENITAL DISLOCATION / DYSPLASIA OF THE HIP AS PRIMARY DIAGNOSIS, THE PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE ASSOCIATED TO THE FEMORAL COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE FEMORAL STEM AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A COMPETITORS FEMORAL SYSTEM. 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 16200160 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2014 TO ADDRESS TAUMA ON THE NECK OF FEMUR, THE PATIENT SUSTAINED A LOSSENING OF THE STEM, DISLOCATION AND SUBLAXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2014 . DURING THIS PROCEDURE, THE MODULAR HEAD, ACETABULAR LINER AND 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: Joint Dislocation; Subluxation

  MAUDE report 16195576 ↗
• MalfunctionMay 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP FOR A THR SURGERY, THE INNER PACKAGING OF THE POLARSTEM STEM STD TI/HA 4 NON-CEM WAS OPEN EVEN THOUGH THE OUTER PACKAGING WAS COMPLETELY SEALED. AS THIS WAS NOTICED BEFORE PROCEDURE, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14352657 ↗
• InjuryMar 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE CLINICAL SUBJECT PRESENTED A CALCAR FRACTURE. THIS FRACTURE WAS DISCOVERED AFTER THE SURGERY UPON CHECKING X RAYS. THE EVENT IS BEING ATTRIBUTED TO THE IMPLANTING OF THE STEM. THE FRACTURE WAS TREATED VIA CERCLAGE WIRE. THE SUBJECT IS RECOVERING POSITIVELY AND THE IMPLANT IS MORE STABLE THAN BEFORE.

  Patient problems: Injury

  MAUDE report 9885099 ↗
• InjuryAug 29, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO SEVERE PAIN AND FRACTURE. DR STATES THAT THIS REVISION WAS NOT CAUSED BY DEVICE BUT PATIENT FELL DOWN.

  Patient problems: Pain

  MAUDE report 8946049 ↗
• InjuryMar 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO DISLOCATION. NO ADDITIONAL DETAILS OF THE REVISION SURGERY REPORTED. FIVE EXPLANTS REPORTED. NO DELAY OR ADDITIONAL INJURIES REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8467981 ↗
• InjuryMar 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT A HIP REVISION SURGERY WAS PERFORMED DUE TO PERI-PROSTHETIC FRACTURE.

  Patient problems: Injury

  MAUDE report 8430111 ↗
• InjuryFeb 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE STEM OF HIP CAME LOOSE, STEM WAS REVISED.

  Patient problems: Injury

  MAUDE report 8364854 ↗
• InjuryMar 10, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  STEM SUBSIDENCE OWING TO FRACTURE AT CALCAR AND GREATER TROCHANTER SURGEON DISSECTED DOWN TO HIP JOINT. DISLOCATED HIP. REMOVED STEM AND BIPOLAR HEAD AS ONE CONSTRUCT USING THE POLARSTEM REMOVAL TOOL PREPARED CANAL FOR ECHELON CEMENTED STEM CEMENTED SIZE 14 175MM ECHELON STEM STD COLLAR. TRIALED BIPOLAR HEAD AND HIP DEEMED STABLE. INSERTED DEFINITIVE BIPOLAR CONSTRUCT ONTO STEM. REDUCED HIP. REDUCED GT FRACTURE AND FIXATED WITH PERIPROSTHETIC PLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7329679 ↗