POLARSTEM 75018402Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07611996103397), received between Mar 14, 2021 and Oct 29, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2024, WHERE THE IMPLANTED STEM WAS UNDERSIZED, THE PATIENT EXPERIENCED PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A POLARSTEM COLLAR STD. TI/HA 2 WAS EXCHANGED WITH A REDAPT STEM AND CABLE. PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20558074 ↗
• 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 AROUND THE STEM, THE PATIENT EXPERIENCED ANOTHER PERI-PROSTHETIC FRACTURE AROUND THE STEM THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE STEM AND 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 16293684 ↗
• InjuryJan 27, 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) 2020 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) 2020. ACCORDING TO THIS REPORT, 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 16253577 ↗
• InjuryJan 27, 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) 2020 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) 2020. 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 16253501 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 DUE TO A FEMORAL STEM SUBSIDED. IT WAS REPLACED WITH A BIGGER IMPLANT. IMPLANTS REMOVED WERE R3 US DELTA HEAD 32 +4 AND POLARSTEM COLLAR STD. TI/HA 2. THERE ARE NO THOUGHTS FROM THE SURGEON THAT THE IMPLANT FAILED. HE BELIEVES IT WAS UNDERSIZED. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 11478996 ↗

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