POLARSTEM 75018403Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07611996103403), received between May 21, 2020 and Feb 3, 2023 — classified as 6 injuries.

1 other recall cover devices cleared under the same FDA submission (K143739); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 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 REVISION SURGERY ON (B)(6) 2018 DUE TO A PERI-PROSTHETIC FRACTURE, THE PATIENT EXPERIENCED ANOTHER PERI-PROSTHETIC FRACTURE THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE STEM AND THE FEMORAL HEAD WERE EXCHANGED 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)

  MAUDE report 16294211 ↗
• InjuryFeb 3, 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) 2021 TO ADDRESS ACUTE TRAUMA 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 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 16291605 ↗
• 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 INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS AN UNSPECIFIED TRAUMA INJURY, THE PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE ASSOCIATED TO THE FEMORAL COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. 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: Hip Fracture

  MAUDE report 16253615 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US LEGAL. IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED IN (B)(6) 2018, THE PATIENT STARTED TO DEVELOP THE FOLLOWING SERIES OF SYMPTOMS: CHRONIC/DEBILITATING PAIN, SI JOINT INFLAMMATION, DIFFICULTY WALKING, LEG LENGTH DISCREPANCY, INSTABILITY, BURSITIS, ISSUES WITH HER VISION THAT REQUIRED SURGERY, HAIR LOSS, SKIN RASH, DIFFICULTY LAYING ON HER SIDE, A CALLUS ON HER HIP AND THE PATIENT CAN HEAR IT MOVE. THIS SITUATION IS ONGOING.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; Joint Laxity; Pain; Unequal Limb Length

  MAUDE report 14503258 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, TWO WEEKS AFTER A REVISION THR SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PUS FROM THE WOUND. THE INFECTION WAS SOLVED VIA TWO-STAGE REVISION SURGERY, WHOSE FIRST LEG TOOK PLACE ON (B)(6) 2021. IMPLANTS WERE REMOVED WITHOUT ISSUE AND A CEMENT SPACER WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Purulent Discharge

  MAUDE report 12829777 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, TWO YEARS AFTER A REVISION SURGERY OF HIP HAD BEEN PERFORMED, IN WHICH A S&N SYSTEM WAS IMPLANTED, THE PATIENT STARTED EXPERIENCING A DETERIORATION IN THE STATE OF HEALTH: EXTREME PAIN, DIFFICULTY FOR WALKING, WEIGHT LOSS, LETHARGIA, AND ANAEMIA. MOBILITY IS BEING ASSISTED WITH WALKING STICKS (INDOORS), ELBOW CRUTCHES (OUTDOORS) AND SCOOTER (LONG DISTANCES). THE PAIN IS BEING MANAGED BY TAKING MORPHINE, PARACETAMOL AND CODEINE. ALTHOUGH X-RAYS, MRI SCANS, NUCLEAR BONE SCAN HAVE BEEN PERFORMED, NOTHING TOTALLY CONCLUSIVE WAS SPOTTED. A REVISION SURGERY WAS PERFORMED BY THE END OF (B)(6) 2020 AND DOCTOR PLANNED TO REMOVE BALL HEAD BUT IT WAS NOTED THAT THE R3 WAS LOOSE AND WORN OUT.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 10081205 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739. One submission often covers many models, so check the product and lot details in each record.

• Z-2827-2020 · Jul 22, 2020 · Open, Classified
  POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the