POLARCUP 75100444Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996118353), received between May 18, 2021 and May 18, 2021 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K122244, 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 18, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A THR, THE PLUG COVER OF A POLARCUP SHELL TI-PLASMA/HA 59 NON-CEM COULDN'T BE REMOVED AND WAS WORN OUT WHILE BEING UNPLUGGED. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THERE WAS A CHANGE OF SURGICAL PROCEDURE DUE TO THE FAILURE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843411 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122244, 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.