POLARSTEM 75102073Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996142334), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Migration; Migration

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2021, A (B)(6) FEMALE PRESENTED WITH INCREASING RIGHT HIP REGION PAIN ON MOBILIZATION. NO REPORTS OF TRIP, FALLS OR INCIDENTS. CT AND X-RAY SHOWED A FRACTURE OF THE PROXIMAL FEMUR WITH SIGNIFICANT STEM SUBSIDENCE. PATIENT MEDICAL HISTORY INCLUDES OVERWEIGHT (BMI NOT KNOWN). ORIGINAL POLARSTEM SUBSIDED, SO THE STEM AND THE HEAD WERE REMOVED. ORIF WAS COMPLETED AND A REDAPT STEM AND A NEW HEAD WERE IMPLANTED ON (B)(6) 2021. THE ORIGINAL SHELL AND LINER WERE RETAINED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN DUE TO HOSPITAL CONFIDENTIALITY POLICY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 12828799 ↗

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