POLARSTEM 75100465Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07611996118568), received between Apr 3, 2019 and May 31, 2026 — classified as 27 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2026Degraded

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCED PREMATURE POLYETHYLENE WEAR. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON UNKNOWN DATE, DURING WHICH THE POLARSTEM STEM STD TI/HA 2 NON-CEM WAS EXCHANGED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25341976 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT, AFTER A HIP REPLACEMENT SURGERY/TREATMENT HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED ISSUES INVOLVING DISLOCATION OF A POLARSTEM STEM STD TI/HA 2 NON-CEM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026 IN WHICH ALL COMPONENTS WERE REMOVED AND THE CUP ALONG WITH ITS METAL LINE WERE REPOSITIONED. IN ADDITION, IT WAS DECIDED TO CEMENT THE FEMORAL CANAL USING THE SAME STEM THAT HAD BEEN IMPLANTED PREVIOUSLY (AN UNCEMENTED STEM), CITING PRIOR EXPERIENCE WITH THIS PRACTICE AS JUSTIFICATION. CURRENT HEALTH STATUS OF PATIENT IS STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 25175033 ↗
• InjuryOct 22, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 BECAUSE THE IMPLANTED POLARSTEM STEM STD TI/HA 2 NON-CEM WAS TWO SIZES SMALLER THAN REQUIRED, SO IT WAS EXPLANTED AND A SIZE 4 POLAR STEM WAS IMPLANTED INSTEAD. THE LINER AND HEAD WERE EXPLANTED AND REPLACED, AS WELL. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20506994 ↗
• InjuryJul 11, 2024Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED SEPTIC SOCKET LOOSENING. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE POLARSTEM STEM STD TI/HA 2 NON-CEM AND THE POLARCUP XLPE INSERT 51/28 NON-CEM WERE EXCHANGED. THE PATIENT IS INDEPENDENTLY MOBILE WITH TWO WALKING STICKS.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Subluxation; Unequal Limb Length

  MAUDE report 19721614 ↗
• InjuryFeb 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A RIGHT THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2018WITH ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, THE PATIENT EXPERIENCED IMPLANT FRACTURE OF THE STEM AND PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2018. ACCORDING TO THE REPORT CONTENTS, THE FEMORAL STEM AND THE MODULAR 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 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); Failure of Implant

  MAUDE report 16287687 ↗
• 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 INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL STEM AND THE MODULAR HEAD WERE EXPLANTED AND REPLACED WITH SIMILAR 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 AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16270810 ↗
• 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 INDEX SURGERY PERFORMED ON (B)(6) 2021 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL STEM AND MODULAR HEAD WERE EXPLANTED AND REPLACED WITH SIMILAR 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 AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16270809 ↗
• 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 INDEX SURGERY PERFORMED ON (B)(6) 2012 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, NONE OF THE DEVICES WERE EXPLANTED NOR REPLACED WITH ANY OTHER 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 AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16270808 ↗
• 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 INDEX SURGERY PERFORMED ON (B)(6) 2013 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER AND THE ACETABULAR CEMENT WERE EXPLANTED AND REPLACED WITH SIMILAR 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 AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 16270805 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT THR ON (B)(6) 2019 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE NEAR THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH SMITH & NEPHEW IMPLANTS. 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 16264436 ↗
• InjuryJan 30, 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) 2019 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE NEAR THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH SMITH & NEPHEW IMPLANTS. 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 16264427 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT THR ON (B)(6) 2019 DUE TO CONGENITAL DISLOCATION/DYSPLASIA OF THE HIP, COMBINED WITH OSTEOARTHRITIS AND PERTHES, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE NEAR THE STEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED WITH SMITH & NEPHEW IMPLANTS. 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 16264418 ↗
• InjuryJan 23, 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) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS AS PRIMARY DIAGNOSIS, THE PATIENT EXPERIENCED A MALALIGNMENT STEM COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE FEMORAL STEM AND THE FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH SIMILAR 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 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: Insufficient Information

  MAUDE report 16223854 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2013 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A LYSIS ¿ STEM, LYSIS ¿ SOCKET, INFECTION AND UNEXPLAINED PAIN THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2013. DURING THIS PROCEDURE, THE FEMORAL STEM AND ACETABULAR CUP WERE EXPLANTED AND REPLACED WITH A COMPETITORS 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: Osteolysis; Pain; Unspecified Infection

  MAUDE report 16218714 ↗
• InjuryJan 20, 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 INDEX SURGERY PERFORMED ON (B)(6) 2013 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERI-PROSTHETIC FRACTURE ¿ STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2013. DURING THIS PROCEDURE, THE FEMORAL STEM WAS EXPLANTED AND REPLACED WITH A COMPETITORS 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: Bone Fracture(s); Insufficient Information

  MAUDE report 16218518 ↗
• InjuryJan 20, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS AS PRIMARY DIAGNOSIS, THE PATIENT EXPERIENCED THE LOOSENING OF THE STEAM COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE FEMORAL STEM AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH SIMILAR 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: Inadequate Osseointegration

  MAUDE report 16214858 ↗
• 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) 2021 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUFFERED FROM A PERI-PROSTHETIC FRACTURE OF THE STEM AND FROM A PERI-PROSTHETIC FRACTURE OF THE CUP, WHICH MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL HEAD AND THE FEMORAL STEM 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)

  MAUDE report 16207063 ↗
• 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 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, 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 16200311 ↗
• InjuryNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, A FEMORAL FRACTURE EXTENDING TO THE DISTAL TIP OF THE PRIMARY HIP STEM WAS NOTICED AFTER X-RAY AND EXAMINATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A POLARSTEM STEM STD TI/HA 2 NON-CEM AND OXINIUM FEM HD 12/14 36 MM L/+8 WERE EXCHANGED WITH A SMITH & NEPHEW REVISION HIP STEM, FEMORAL HEAD, AND SEVERAL CABLES. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Hip Fracture

  MAUDE report 15875770 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THR, THE FEMUR FRACTURED WHEN IMPLANTING POLARSTEM STEM. THIS WAS EVENT WAS TREATED BY CABLE TO FASTEN FRACTURED FEMUR. PATIENT HAS RECOVERED.

  Patient problems: Limb Fracture

  MAUDE report 13689315 ↗
• InjuryFeb 1, 2022Adverse 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED SQUEAKING AND PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE POLARSTEM STEM STD TI/HA 2 NON-CEM AS THE SURGEON FELT THERE WAS TOO MUCH ANTE VERSION. THE STRIPE WEAR ON HEAD WAS IN A SUPERIOR POSTERIOR POSITION. IT IS UNKNOWN CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13407619 ↗
• InjuryJul 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE PLASTIC COVER ON A POLARSTEM STEM STD TI/HA 2 NON-CEM NECK BROKE WITHOUT ANY FORCE OR PRESSURE APPLIED TO IT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM SINCE ALL THE FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159859 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. ELEVATED TEMPERATURE AND CRP NOTED. ALL IMPLANTS REMOVED AND CEMENT SPACER IMPLANTED. THE SURGEON DOES NOT ATTRIBUTE BLAME TO PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 11712917 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY THR ON (B)(6) 2020 AND SHOWED SIGNS OF INFECTION AND THIS WAS CONFIRMED BY PATHOLOGY. REVISION SURGERY PERFORMED USING CPCS AND ALL POLY REFLECTION CUP WITH COPAL ANTIBIOTIC CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355518 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PRIMARY SURGERY (THR), THE PATIENT HAD A LESSER TROCHANTER FRACTURE WHICH CAUSED THE IMPLANT TO SINK. UNKNOWN CAUSE OF THE FRACTURE. THE SURGEON DID NOT BELIEVE THE FRACTURE TO BE CAUSED BY THE DEVICE. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE. ALL X-RAYS AND MEDICAL RECORDS AVAILABLE HAVE BEEN ATTACHED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10492206 ↗