POLARSTEM 75102076Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996142365), received between Apr 1, 2021 and Sep 30, 2022 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K143739, K211176); 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 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE PATIENT EXPERIENCED AN INTRAOPERATIVE FEMUR FRACTURE. THIS ADVERSE EVENT WAS TREATED BY AN INTRAOPERATIVE OPEN REDUCTION BONE REPAIR. SURGERY WAS COMPLETED WITH THE SAME DEVICES. IT IS UNKNOWN IF THERE WAS A DELAY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 15519256 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER IMPLANTATION OF THE LEFT SIDE OF THE POLAR STEM, THE PATIENT UNDERWENT A RIGHT TKA REVISION SURGERY. THE DATE OF SURGERY IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11605696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• 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