POLARSTEM 75100474Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07611996118650), received between Dec 18, 2019 and Apr 16, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2025, IT WAS NOTICED THAT THE POLARSTEM STEM LAT.TI/HA 1 NON-CEM WAS UNDERSIZED, CAUSING IT TO SUBSIDE AND MOVE IN THE FEMUR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 TO ADDRESS THIS PROBLEM AND EXCHANGE THE STEM TO A 3 LATERALIZED POLARSTEM, FOR A BETTER PROXIMAL FIT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24897349 ↗
• InjuryJan 31, 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) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. 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 16272258 ↗
• 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 THR SURGERY PERFORMED ON (B)(6) 2017 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. 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 16258278 ↗
• InjuryJan 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT COLLAPSED THROUGH HIS RIGHT HIP, AND A SUBSEQUENT X-RAY SHOWED THAT THE NECK OF THE STEM HAD BROKEN OFF. A SECOND REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO EXCHANGE THE HEAD, LINER AND STEM. ALTHOUGH THE REVISION SURGERY WENT WELL, THE CLIENT IS STILL EXPERIENCING VERY SEVERE DISCOMFORT ON THE RIGHT HIP. THE PATIENT HAD THE PRIMARY POLARSTEM - REFLECTION RIGHT HIP SURGERY ON (B)(6) 2017 AND UNDERWENT THE FIRST REVISION SURGERY ON (B)(6) 2017, WHEN THE OXINIUM FEMORAL HEAD WAS REPLACED WITH A LARGER ONE.

  Patient problems: Failure of Implant

  MAUDE report 16254472 ↗
• InjuryJan 20, 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) 2017 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT PRESENTED A PERI-PROSTHETIC FRACTURE THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE FEMORAL HEAD AND THE STEM 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: Bone Fracture(s)

  MAUDE report 16215419 ↗
• InjuryJan 19, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2021 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUFFERED FROM LOOSENING OF THE STEM, WHICH MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL STEM AND THE FEMORAL HEAD 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: Inadequate Osseointegration

  MAUDE report 16210172 ↗
• InjuryJan 18, 2023Failure to Osseointegrate; Failure to Osseointegrate

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

  MAUDE report 16200265 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2022, THE PATIENT HAD AN INFECTION. A REVISION SURGERY WAS ADDRESSED TO EXPLANT ALL THE IMPLANTS (OXONIUM FEM HD 12/14 32 MM +4, R3 20 DEG XLPE ACET LNR 36 MM X 52 MM, R3 0 HOLE HA CTD ACET SHELL 52 MM, REF INTERFIT THRD HOLE COVER AND POLARSTEM STEM LAT.TI/HA 1 NON-CEM) AND INSERT CEMENT SPACERS. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 15274468 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO ACCUMULATING WATER. THE POLARSTEM STEM LAT.TI/HA 1 NON-CEM WAS EXPLANTED. THE SURGEON SAYS IT WAS NOT CAUSED BY INFECTION. NO CAUSATIVE MICROORGANISM (BACTERIA) IS DETECTED. ALSO, THE SURGEON DID NOT THINK S+N DEVICES WERE DEFECTIVE. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Swelling/ Edema

  MAUDE report 13619488 ↗
• InjuryJan 28, 2022Migration; Migration

  IT WAS REPORTED THAT AFTER A FEW MONTHS OF THE SURGERY THAT HAVE BEEN PERFORMED ON (B)(6) 2021, THE PATIENT FELL LEADING TO THE POLARSTEM STEM LAT.TI/HA 1 NON-CEM SUBSIDING AND NEEDING TO BE REVISED ON (B)(6) 2021. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13389259 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12537167 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM AN EVENT FIRST MONTH AFTER PRIMARY SURGERY. AT THIS TIME, SURGEON REVIEWED X-RAYS AND FELT THAT THERE HAD BEEN A SMALL AMOUNT OF SUBSIDENCE SINCE IMMEDIATE POST OP X-RAYS WERE TAKEN. IT WAS IDENTIFIED THAT THE DISTAL TIP OF THE STEM ON PRIMARY IMPLANTATION HAD POSSIBLY RESTED UPON AN AREA OF SCLEROTIC BONE CHANGE WITHIN THE CANAL. SURGEON AND PATIENT DECIDED TO SEE IF THE DISCOMFORT WOULD SETTLE AND REVIEW AFTER CHRISTMAS/NEW YEAR PERIOD. THE DISCOMFORT DIDN'T SETTLE AND MORE X-RAYS WERE ORDERED, A LESION WAS VISIBLE AT THE LEVEL OF THE DISTAL TIP OF STEM AND THE STEM HAD NOTICEABLY SUBSIDED TO THE LEVEL OF THE BOTTOM OF THIS LESION. THE SURGEON FELT THE STEM WAS LOOSE AND NOT LIKELY TO INTEGRATE AT THIS POINT, AND IT WAS DECIDED TO UNDERTAKE A STEM REVISION. PRIMARY SURGERY WAS ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 11320819 ↗
• InjuryDec 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY OF POLARSTEM STEM LAT.TI/HA 1 NON-CEM WAS PERFORMED DUE TO BREAKAGE OF THE STEM. STEM, HEAD, LINER AND CUP WERE REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 11016918 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A HIP- PERI-PROSTHETIC HIP FRACTURE. THE PRIMARY HIP REPLACEMENT PROCEDURE WAS (B)(6) 2020. THE POLARSTEM LATERAL SIZE 1 AND EXISTING CO-CR FEMORAL HEAD 32+4 WERE REMOVED AND THE REDAPT FEMORAL STEM SIZE 15H, 190MM AND NEW COCR HEAD 32+4 WERE IMPLANTED.

  Patient problems: Hip Fracture

  MAUDE report 10376878 ↗
• InjuryDec 18, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAD PERIPROSTHETIC HIP FRACTURE AND A LOOSE STEM. A REVISION SURGERY WAS PERFORMED TO RESOLVE THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 9489013 ↗