POLARCUP 75100443Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996118346), received between May 12, 2021 and May 12, 2021 — classified as 1 malfunction.

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.

• MalfunctionMay 12, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A THA, UPON OPENING THE STERILE PACKAGING OF A POLARCUP SHELL TI-PLASMA/HA 57 NON-CEM, IT WAS TRIED TO REMOVE THE PLUG COVERS IN THE DIRECTION THAT WAS INDICATED ON THE PLUG COVER. HOWEVER, THE CAP GOT STUCK AND COULD NOT COME OUT: THE THREAD WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814101 ↗

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.