POLARSTEM 75018400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996103373), received between Jan 27, 2023 and Sep 8, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Adverse 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) 2019, THE PATIENT EXPERIENCED GROIN PAIN DUE TO EARLY DEGENERATIVE CHANGES IN THE LUMBAR BACK, POSSIBLY RELATED TO TENDONITIS. THE PATIENT RECEIVED PHYSICAL THERAPY AND A STEROID INJECTION AS TREATMENT. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Tendinopathy

  MAUDE report 22999416 ↗
• 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) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE ASSOCIATED TO THE FEMORAL COMPONENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. ACCORDING TO THIS REPORT, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW FEMORAL HEAD. 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 16253415 ↗

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